Safety
-
Enforcement Report for February 29 2012
February 29, 2012 12-09
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I
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PRODUCT
OLD LABELING: Paper Bag labeled in part: Front of bag - "Flamingo Poop Deluxe Chocolate Candy Net Weight 6 oz***". Back of bag - "***Flamingo Poop***Deluxe Chocolate Mix Nutrition facts Ingredients: Milk Chocolate, Sugar, Chocolate liquor, cocoa butter, Whole milk powder, anhydrous, butter oil, soya lecithin (emulsifier, Salt, vanillin, (artificial flavor), sweet chocolate(sugar, corn syrup, Peanuts, sweetened condensed whole milk, (condensed whole milk, sugar, Whey, maltodextrins, malted milk powder, (malted barley, wheat flour, Milk, sodium bicarbonate, salt), soy lecithin, malt syrup, modified Food starch, cocoa powder, salt, Sorbitan Tristearate, egg whites, Natural and artificial flavors, citric acid invertase, caramel color, FD&C colors (Red 3, Red 40, Yellow 5, Blue 1) Gum Arabic, confections glaze***Allergen Alert: Contains Peanuts***" NEW/CORRECTED LABELS: Paper bags are labeled in part: Front of bag- "***FLAMINGO POOP DELUXE CHOCOLATE CANDY Net Weight 6 oz***" Back of bag - "***Flamingo Poop***Serving Size 1/4 cup (40 g)***Servings Per container 4***Allergen Alert: May contain Peanuts, Tree Nuts, Whet, Milk, Egg & Soy***Chocolate Lore: To reduce calories, store your chocolate on top of the refrigerator. Calories are afraid of heights and will jump out of the chocolate to save themselves.***Deluxe Chocolate Mix***Ingredients: Sugar, Chocolate liquor, Cocoa butter, Whole milk powder, Soya lecithin & pgpr (emulsifiers), Whole milk, cocoa powder, Vanilla (artificial flavors) Salt, Partially hydrogenated vegetable & Palm kernel oil (coconut & palm) whey powder, Whey, Malted milk, Cocoa may be processed with alkali. (Malted barley, wheat flour, milk, bicarbonate of soda, salt) Malt extract, Coconut oil, Glycerol monostearate, Artificial flavors, Gun arabic, Raisins (treated in vegetable oil) Peanuts, almonds, Brazil nuts, Cashews, Pecans, Filberts, Walnuts (roasted in cottonseed oil), Corn syrup, Confectioners glaze.***" Chocolate Mix was re-packed and distributed under the following names: Flamingo Poop UPC 8 27912 06117 8 (50 bags in distribution) Pelican Poop UPC 8 27912 06007 2 (50 bags in distribution) Florida Gator Poop UPC 8 27912 07857 2 (300 bags in distribution) Shark Bites UPC 8 27912 01662 8 (50 bags in distribution) Manatee Smoochies UPC 8 27912 01342 9 (50 bags in distribution). Except for the brand name and logo all 5 bags have identical labels and contents/formulation. Recall # F-0775-2012
CODE
None
RECALLING FIRM/MANUFACTURER
Mar-Len Confections dba Florida Chocolate Specialties, Largo, FL, by telephone and visit between March 23, 2011 and April 1, 2011. Firm initiated recall is ongoing.
REASON
Recall due to incomplete product labeling-product was not labeled as containing tree nuts.
VOLUME OF PRODUCT IN COMMERCE
500 bags
DISTRIBUTION
FL, NC
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PRODUCT
Product is labeled in part: "***Anytime Deli Turkey & Ham Footlong***GOOD THRU 01/xxx/12***KEEP REFRIGERATED***Allergens: Wheat, Soy, Egg, and Milk***ham and turkey foot long*** 7 05432 00194 5***KEEP REFRIGERATED***Total Weight: 12.20 oz-wt. ((345.87g)”. Recall # F-0776-2012
CODE
1/19/2012 and 1/22/2012
RECALLING FIRM/MANUFACTURER
M.E. Thompson Inc., Jacksonville, FL, by visit on January 23, 2012 and press release on January 25, 2012. Florida initiated recall is ongoing.
REASON
Product tested positive for Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
2,200 sandwiches
DISTRIBUTION
FL and S. GA
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PRODUCT
Humei Foods brand DRIED PACHYRHIZUS, Net Wt. 350G (12.32 oz), PRODUCT OF CHINA, UPC 6 922601 401090 --- Nutrition Facts: Serving Size 175g, Serving about 2. The product is packaged in a sealed flexible plastic bag. Recall # F-0777-2012
CODE
None
RECALLING FIRM/MANUFACTURER
Humei Trading Inc., Jamaica, NY, by press release and letters on April 29, 2010. New York initiated recall is complete.
REASON
The product contained undeclared sulfites (794 ppm) based on sampling and analysis by New York State Department of Agriculture & Markets.
VOLUME OF PRODUCT IN COMMERCE
49 cases
DISTRIBUTION
NY
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PRODUCT
1) deLISH egg salad on honey wheat; Net Wt. 8.5 oz (241 g) Freshly chopped hard boiled eggs with lite mayonnaise, celery, green and yellow onions & lemon pepper seasoning on honey whole wheat bread. UPC 0 49022 51925 1; Sandwiches are packaged in a cellophane wrapper. Recall # F-0778-2012;
2) deLISH Tuna salad on multigrain bread; Net Wt. 8.5 oz (241 g) Yellowfin tuna with lite mayonnaise, onions & lemon pepper seasoning on multigrain bread. Product is packaged in a cellophane wrapper; UPC 0 49022 51928 2. Recall # F-0779-2012
CODE
1) Enjoy by Date: 1/17/12 through 2/5/2012;
2) Enjoy by Date: 1/22/12 through 2/5/2012
RECALLING FIRM/MANUFACTURER
Recalling Firm: GH Foods CA LLC, Sacramento, CA, by press release, telephone and e-mail on February 3, 2012.
Manufacturer: M G Waldbaum Co dba Michael Foods, Wakefield, NB. Firm initiated recall is ongoing.
REASON
GH Foods CA was notified by their supplier that the eggs supplied to them were from Michael Foods Inc who recalled the eggs due to potential contamination with Listeria.
VOLUME OF PRODUCT IN COMMERCE
1) 1,202; 2) 889
DISTRIBUTION
CA
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PRODUCT
1) Sugar Free Oregon Marionberry Pie is sold under the brand name Kris' Kitchen. The product is fruit filling, 9" up to 13" deep dish pie. The whole pie is packaged in a box with a plastic window. The product is labeled in parts: "***Sugar Free Oregon Marionberry Pie***Crust: Unbleached flour (wheat flour, malted barley flour, niacin, iron, thiamin mononitrate, riboflavin, folic acid), butter flavored Crisco [soybean oil, fully hydrogenated cottonseed oil, partially hydrogenated cottonseed and soybean oils, mono and diglycerides, natural and artificial butter flavors, TBHQ and citric acid (antioxidants), beta-carotene (pro vitamin A) added for color], water, eggs, apple cider vinegar, sea salt***Filling: Marionberries, Splenda, cornstarch***Allergen Information: Contains wheat, eggs, corn, and soy”. Recall # F-0780-2012;
2) Oregon Wild Blackberry Pie is sold under the brand name Kris' Kitchen. The product is fruit filling, 9" up to 13" deep dish pie. The whole pie is packaged in a box with a plastic window. The product is labeled in parts: "***Oregon Wild Blackberry Pie***Crust: Unbleached flour (wheat flour, malted barley flour, niacin, iron, thiamin mononitrate, riboflavin, folic acid), butter flavored Crisco [soybean oil, fully hydrogenated cottonseed oil, partially hydrogenated cottonseed and soybean oils, mono and diglycerides, natural and artificial butter flavors, TBHQ and citric acid (antioxidants), beta-carotene (pro vitamin A) added for color], water, eggs, apple cider vinegar, sea salt***Filling: Wild Blackberries, granulated sugar, cornstarch***Allergen information: Contains wheat, eggs, corn, and soy". Recall # F-0781-2012;
3) Peach Pie is sold under the brand name Kris' Kitchen. The product is fruit filling, 9" up to 13" deep dish pie. The whole pie is packaged in a box with a plastic window. The product is labeled in parts: "***Peach Pie***Crust: Unbleached flour (wheat flour, malted barley flour, niacin, iron, thiamin mononitrate, riboflavin, folic acid), butter flavored Crisco [soybean oil, fully hydrogenated cottonseed oil, partially hydrogenated cottonseed and soybean oils, mono and diglycerides, natural and artificial butter flavors, TBHQ and citric acid (antioxidants), beta-carotene (pro vitamin A) added for color], water, eggs, apple cider vinegar, sea salt***Filling: Peaches, granulated sugar, cornstarch***Allergen information: Contains wheat, eggs, corn, and soy***". Recall # F-0782-2012
CODE
None
RECALLING FIRM/MANUFACTURER
Kristina Krabills Kitchen LLC, Lebanon, OR, by visit on January 19, 2012. FDA initiated recall is complete.
REASON
Products contains milk but the label does not declare milk.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
OR
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PRODUCT
1) Jones' Mock Salt Original are sold under the Jones brand name. The product is packaged in 1.6 oz bottles, 12 oz. bags, or 16 oz. bags. The UPC information is listed as below: 1.6 oz bottles-UPC 0 94922 16616 6; 12 oz bags- UPC 0 94922 07199 6; 16 oz bags- UPC 0 94922 16616 6. The Jones' Mock Salt Original product is labeled in parts: "***Ingredients: organic garlic, cream of tartar, organic jasmine rice, organic onion, organic celery seed, organic arrowroot, organic evaporated cane juice, organic black pepper, organic parsley, organic orange peel, citric acid, organic white pepper, organic cayenne pepper, organic dill, organic sage, and organic peel***". Recall # F-0783-2012;
2) Jones' Mock Salt Spicy Southwest Blend is sold under the Jones' brand name. The product is packaged in 1.6 oz bottles. The UPC is 0 94922 01560 0. Jones' Mock Salt Spicy Southwest Blend product is labeled in parts: "***Jones' MOCK SALT ORGANIC Spicy Southwest Blend***Net Wt. 1.6 oz***Ingredients: organic garlic, organic orange peel, organic jasmine rice, cream of tartar, organic onion, organic arrowroot, organic celery seed, organic jalapeno, organic red pepper, organic evaporated cane juice, organic oregano, citric acid, organic cumin, organic cilantro, organic black pepper***". Recall # F-0784-2012
CODE
None
RECALLING FIRM/MANUFACTURER
Jones Seasoning Blends LLC, Tacoma, WA, by telephone on December 22, 2011 and letter dated January 6, 2012 and by press release on January 23, 2012. Firm initiated recall is ongoing.
REASON
Recall due to possible contamination of Salmonella.
VOLUME OF PRODUCT IN COMMERCE
1) 475/1.6 oz Bottles; 11/12 oz. Bags; 5/16 oz. Bags; 2) 738/1.6 oz bottles
DISTRIBUTION
Nationwide
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PRODUCT
Hard cooked peeled eggs packaged in 25-lb. tubs with the following labels: (1) Papetti's Table Ready Hard-Cooked Select Peeled Eggs, 46025-63301, UPC 1 07 46025 63301 0; (2) Columbia Valley Farms Chef Grade Perfect Hard Cooked Peeled Eggs, 10994, UPC 000 41493, 10994 8; (3) GFS Hard Cooked Peeled Eggs in Brine, 711160, UPC 0 00 93901 71116 8; (4) SilverBrook Hard Cooked Eggs, 16188, UPC 0 08 22486 16188 0; (5) Wholesome Farms Hard Cooked Peeled Eggs, 8847505, UPC 7 34730 25506 4; (6) Wholesome Farms Chef Grade Hard Cooked Peeled Eggs, 8847491, UPC 7 34730 25505 7; and (7) Glenview Farms Deluxe Peeled Hardcooked Eggs in Brine, 368821, UPC 5 07 58108 43734 5; Hard cooked peeled eggs packaged in 10-lb. tubs with the following labels: (1) Papetti's Hard-Cooked Select Peeled Eggs, 46025-62102, UPC 1 07 46025 62102 4; (2) Wholesome Farms Chef Grade Hard Cooked Peeled Eggs 1403898, UPC 0 74865 56841 8; and (3) Glenview Farms Peeled Hardcooked Eggs in Brine, 080431, UPC 7 58108 11442 5; Hard cooked peeled eggs packaged in 10-kg. tubs labeled as GFS Oeufs Peles Cuits Durs. Recall # F-0785-2012
CODE
Lot 1350W, Use by 1/30/2012; Lot 1351W, Use by 1/31/2012; Lot 1353W, Use by 2/2/2012; Lot 1354W, Use by 2/3/2012; Lot 1355W, Use by 2/4/2012; Lot 1356W, Use by 2/5/2012; Lot 1357W, Use by 2/6/2012; Lot 1361W, Use by 2/10/2012; Lot 1362W, Use by 2/11/2012; Lot 1363W, Use by 2/12/2012; Lot 1364W, Use by 2/13/2012; Lot 2003W, Use by 2/17/2012; Lot 2004W, Use by 2/18/2012; Lot 2005W, Use by 2/19/2012; Lot 2006W, Use by 2/20/2012; Lot 2009W, Use by 2/23/2012; Lot 2010W, Use by 2/24/2012; Lot 2011W, Use by 2/25/2012; Lot 2012W, Use by 2/26/2012; Lot 2016W, Use by 3/1/2012; Lot 2017W, Use by 3/2/2012; Lot 2018W, Use by 3/3/2012; Lot 2019W, Use by 3/4/2012; and Lot 2023W, Use by 3/8/2012
RECALLING FIRM/MANUFACTURER
Recalling Firm: Michael Foods, Inc., Minnetonka, MN, by telephone and e-mail on January 26, 2012 and January 31, 2012 and by press release on February 1, 2012.
Manufacturer: Michael Foods Egg Products Co., Wakefield, NB. Firm initiated recall is ongoing.
REASON
Listeria monocytogenes was found in some of the lots of hard cooked eggs.
VOLUME OF PRODUCT IN COMMERCE
14,767/25-lb. tubs, 869/10-lb. tubs, and 470/10-kg. tubs
DISTRIBUTION
Nationwide and Canada
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PRODUCT
Organic Jam my Sam my snack size sandwich bars: Strawberry jam and peanut butter; 5 - 1. 3 oz bars per box. 5 Carton count; UPC: 8 96766 00116 6. Recall # F-0786-2012
CODE
Exp 6/2012.
RECALLING FIRM/MANUFACTURER
Recalling Firm: The Nest Collective, Inc., dba Plum Organics, Emeryville, CA, by telephone and e-mail on February 3, 2011.
Manufacturer: Bridgetown Natural Foods, Portland, OR. Firm initiated recall is ongoing.
REASON
Product contains peanut butter that is not listed on the ingredient statement of the wrapper.
VOLUME OF PRODUCT IN COMMERCE
815 cases
DISTRIBUTION
Nationwide
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PRODUCT
Walgreen Chocolate Covered Raisins in a 13 oz. blue and white plastic bag with the product pictured on the label, UPC 04902245661, item number 280217. Recall # F-0791-2012
CODE
Best by date Oct 42012A1
RECALLING FIRM/MANUFACTURER
GKI Foods, Inc., Brighton, MI, by telephone and letter beginning January 25, 2012 and press release on January 28, 2012. Firm initiated recall is ongoing.
REASON
Walgreen Co. is voluntarily recalling certain lots of 13-oz. Walgreens Chocolate Covered Raisins because the packages may contain Walgreen Bridge Mix with peanuts, almond and soy ingredients. The labeling mix-up was discovered after Walgreen Co received a consumer complaint involving an allergic reaction to the unlisted ingredients.
VOLUME OF PRODUCT IN COMMERCE
553 units
DISTRIBUTION
Nationwide
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PRODUCT
Gourmet Family brand LARGE MOUTH SMELT (KOMOCHI SHISHAMO) -- Net Wt. 3.5 oz. (100G.) -- UPC 4 969523 080011 -- Product of Japan -- KEEP FROZEN. The product is vacuum packed in a styrofoam tray. Recall # F-0792-2012
CODE
None
RECALLING FIRM/MANUFACTURER
Recalling Firm: Daiei Trading Co, Inc., College Point, NY, by letters dated March 1, 2011 and press release on March 2, 1011.
Manufacturer: Maruman Yamada Suisan Co., LTD. (Ariake Branch), Soo-Gun, Japan. New York initiated recall is complete
REASON
The product was found to be uneviscerated based on sampling and analysis by New York State Department of Agriculture & Markets.
VOLUME OF PRODUCT IN COMMERCE
279 cases (20 x 3.5 oz. packs per carton)
DISTRIBUTION
NY, NJ, CT, MA, PA, MD, VA, NC, GA, FL and TX
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PRODUCT
1) Spartan Fresh Selections Seven Layer Salad 12 oz. Allergen Information: CONTAINS SOY, MILK, and EGG. Recall # F-0799-2012;
2) Spartan Fresh Selections Small Chef 4 oz. Allergen Information: CONTAINS MILK and EGG. Recall # F-0800-2012;
3) Spartan Fresh Selections Chef Salad 10 oz; Allergen Information: CONTAINS MILK and EGG. Recall # F-0801-2012;
4) Spartan Fresh Selections Egg Spread 5 lb; Keep Refrigerated. Recall # F-0802-2012;
5) Spartan Egg Salad 4 oz and Spartan Fresh Selections Egg Salad 4 oz. Allergen Information: CONTAINS WHEAT, SOY, MILK, and EGG. Recall # F-0803-2012;
6) Spartan Small Chef 4 oz. Allergen Information: CONTAINS MILK and EGG. Recall # F-0804-2012;
7) Spartan Seven Layer Salad 12 oz. Allergen Information: CONTAINS SOY, MILK, and EGG. Recall # F-0805-2012;
8) Spartan Chef Salad 10 oz. Allergen Information: CONTAINS MILK and EGG. Recall # F-0806-2012
CODE
Sell by: 1-20-12 through 2-1-12: all codes Production dates: 1-18-12 through 1-28-12
RECALLING FIRM/MANUFACTURER
Spartan Stores, Grand Rapids, MI, by press release and e-mail on January 27, 2012. Firm initiated recall is ongoing.
REASON
The recall is in connection with the voluntary recall announced today by Michael Foods of their hard cooked egg products due to possible contamination with Listeria Monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
6,274
DISTRIBUTION
MI
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PRODUCT
Chicken Salad Sandwiches sold under the following brand names: 1) Grand Strand Sandwich, Chicken Salad, 4.5oz, UPC: 067068101056; 2) Lunch Box, Chicken Salad, 4.5oz, UPC: 067068101050; 3) Country Harvest Deli, Chicken Salad, 5oz, UPC: 067068171059. Recall # F-0825-2012
CODE
1) Sell by: 02/24/12 and 2/29/2012; 2) Sell by 02/24/12; 3) Sell by 02/23/12
RECALLING FIRM/MANUFACTURER
Recalling Firm: Grand Strand Sandwich Co., Inc., Longs, SC, by telephone and email on February 4, 2012 and by press release on February 7, 2012.
Manufacturer: Bost Distributing Co., Sanford, NC. Kansas initiated recall is ongoing.
REASON
Products contain hard cooked eggs produced by Michael Foods, Inc., Wakefied, NE that was found to be contaminated with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
2,874 sandwiches
DISTRIBUTION
NC, NJ, PA and SC
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II
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PRODUCT
Shakleebaby Multivitamin & Multimineral Powder for Infants and Toddlers. Dietary Supplement Net Wt 4.2 oz / 120 g Mix 1 tsp in 4 ounces of juice, water or food. Mixture does not mix well with milk. Serving size 1 teaspoon. Recall # F-0793-2012
CODE
Lot AR1E01, Exp 10/12. Lot AR9K01, Exp 4/11
RECALLING FIRM/MANUFACTURER
Recalling Firm: Shaklee Corp., Pleasanton, CA, by letters on January 24, 2012. Manufacturer: Arnet Pharmaceutical Corp., Davie, FL. Firm initiated recall is ongoing.
REASON
During an audit of the product manufacturer, it was discovered that two batches of product have an iodine level higher than that claimed on the label. Label claim is 35 mcg per serving; test found levels for 756/4 g to 1820 mcg.
VOLUME OF PRODUCT IN COMMERCE
8882 bottles
DISTRIBUTION
Nationwide
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PRODUCT
Mashed Potatoes (made from Simplot Traditions 100% Real Seasoned Potato Flakes). Recall # F-0795-2012
CODE
"Sell by 01/28/2012"
RECALLING FIRM/MANUFACTURER
Recalling Firm: Giant Eagle, Pittsburgh, PA, by e-mail on January 27, 2012. Manufacturer: J R Simplot Co Inc., Food Division, Caldwell, ID. Firm initiated recall is ongoing.
REASON
The product contains undeclared soy lecithin.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
MD, OH, PA and WV
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PRODUCT
1) Vegetable dip in 8oz size polypropylene container sold individually or 12 per case. Each container labeled in part: "ORIGINAL RECIPE Artichoke PARMESAN Dip & Spread***Ingredients: Artichokes, Mayonnaise (soybean oil, eggs, corn syrup, water, vinegar, egg yolks, salt, lemon juice), Parmesan cheese, garlic, salt, lemon juice, spices.***" Recall # F-0796-2012;
2) Vegetable dip in 8oz size polypropylene container sold individually or 12 per case. Each container labeled in part: "GARLIC LOVERS Artichoke PARMESAN Dip & Spread***Ingredients: Artichokes, Mayonnaise (soybean oil, eggs, corn syrup, water, vinegar, egg yolks, salt, lemon juice), Parmesan cheese, garlic, salt, lemon juice, spices.***" Recall # F-0797-2012
3) Vegetable dip in 8oz size polypropylene container sold individually or 12 per case. Each container labeled in part: "JALAPENO Artichoke PARMESAN Dip & Spread. Ingredients: Artichokes, Mayonnaise (soybean oil, eggs, corn syrup, water, vinegar, egg yolks, salt, lemon juice), jalapeno peppers, parmesan cheese, water, minced garlic, lemon juice, black pepper." Recall # F-0798-2012
CODE
1) Containers labeled with a "Sell by" date that is 6 weeks from the date of production. Affected codes are: "Sell by 2/7/12", "Sell by 2/15/12", "Sell by 2/21/12", "Sell by 2/29/12", "Sell by 3/6/12", and "Sell by 3/13/12";
2) Containers labeled with a "Sell by" date that is 6 weeks from the date of production. Affected codes are: "Sell by 2/7/12", "Sell by 2/15/12", "Sell by 2/21/12", "Sell by 2/29/12", "Sell by 3/6/12", and "Sell by 3/13/12";
3) Containers labeled with a "Sell by" date that is 6 weeks from the date of production. Affected codes are: "Sell by 2/7/12", "Sell by 2/15/12", "Sell by 2/21/12", "Sell by 2/29/12", "Sell by 3/6/12", and "Sell by 3/13/12"
RECALLING FIRM/MANUFACTURER
Stubblefield Enterprises, Inc. dba, De Casa Fine Foods, Eugene, OR, by visit beginning February 2, 2012.
REASON
The product contains undeclared milk but cheese is listed as an ingredient.
VOLUME OF PRODUCT IN COMMERCE
1) 926 8 oz.; 2) 858 8 oz.; 3) 353 8 oz
DISTRIBUTION
OR, WA
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PRODUCT
1) Trader Joe's English Toffee with Milk Chocolate, 8 oz; SKU 00483032. Recall # F-0808-2012;
2) President's Choice Milk Chocolate Almond Bark, 195 g (Loblaws Canada)
SKU 060383010720. Recall # F-0809-2012;
3) President's Choice Milk Chocolate Covered Butter Toffee with Roasted Almonds, 195 g (Loblaws Canada); SKU 060383010676. Recall # F-0810-2012;
4) President's Choice Milk Chocolate and Almond Caramel Clusters, 195 g (Loblaws Canada); SKU 060383010744. Recall # F-0811-2012;
5) Cherrydale Farms Assorted Gourmet Chocolate Bars (Fundraising Box), No SKU. Recall # F-0812-2012;
6) Cherrydale Farms Gold, Milk Chocolate Almond, 1.5 oz. No SKU. Recall # F-0813-2012;
7) Chateau Chocolat Milk Chocolate Almond Coconut Clusters, 9 oz; SKU 075655323323. Recall # F-0814-2012;
8) Bazzini Holdings LLC Almond Butter Toffee, 6 oz; SKU 075062780085. Recall # F-0815-2012;
9) Honey Nut & Seed Crunch, 30 lbs (prod # 50213) and 10 lbs (prod #50214). A L Bazzini; SKU 075062502137 (30 lb) and SKU 075062502144 (10 lb). Recall # F-0816-2012;
10) House of Bazzini Honey Nut & Seed Crunch, 3 oz, SKU 075062000206. Recall # F-0817-2012;
11) Bazzini Old Fashioned RST Almond Butter, 16 oz, SKU 075062840116. Recall # F-0818-2012;
12) Bazzini Old Fashioned Almond Butter, Raw, 16 oz, SKU 075062840093.
Recall # F-0819-2012;
13) Barricini Dark Chocolate Coconut Almond Patties, 2 oz, SKU 075655390202. Recall # F-0820-2012;
14) Towsley's Almond Butter Toffee, 4 oz bag, SKU 61340. Recall # F-0821-2012;
15) A.L. Bazzini Almond Butter Roasted Chunky, 33 lb, SKU 075062840505. Recall # F-0822-2012;
16) A.L. Bazzini Raw Almond Butter, 6.5 lb tin. Item # 84051, SKU 075062840512. Recall # F-0823-2012
CODE
None
RECALLING FIRM/MANUFACTURER
Bazzini Holdings L.L.C., Allentown, PA, by e-mail and letters on October 19, 2011. Firm initiated recall is ongoing.
REASON
Alleged glass fragments in product.
VOLUME OF PRODUCT IN COMMERCE
372,758
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
Brown outer cardboard box : Little Caesars Cookie Dough Fundraising Program, Family Size cookie dough with Break and Bake convenience, Refrigerate or Freeze Immediately, sealed with red taped labeled Peanut Butter Chocolate Chip. 4 Inner flexible plastic packages, labeled Little Caesars Cookie Dough, 15 premium cookies, Chocolate Chip NOT INTENDED FOR SEPARATE SALE NET WT. 14 OZ (454g) NEW Break-n-Bake Convenience! Chocolate Chip: Contains Wheat, Milk, Eggs and Soy. Oatmeal Raisin: Contains Wheat, Milk, Eggs and Soy. Peanut Butter Chocolate Chip: Contains Wheat, Milk, Eggs, Soy and Peanuts. White Chocolate Macadamia Nut: Contains Wheat, Milk, Eggs, Soy and Tree Nuts (Macadamia Nuts). ALLERGEN INFORMATION: Manufactured on equipment that processes products containing peanuts and tree nuts. For nutritional and ingredient information, see outer box. Recall # F-0824-2012
CODE
NB 01212
RECALLING FIRM/MANUFACTURER
Champion Foods, LLC, New Boston, MI, by telephone and e-mail beginning February 10, 2012. Firm initiated recall is ongoing.
REASON
Product is being recalled due to incorrect labeling of the inner product packaging. The outer box is labeled correctly, but the interior packaging (four 14 oz. Break-n-Bake Cookie Dough packages) is mistakenly labeled as Chocolate Chip without a reference to Peanut Butter.
VOLUME OF PRODUCT IN COMMERCE
434 boxes (4 pkgs. each)
DISTRIBUTION
MI, NH, MO
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS III
PRODUCT
Price Chopper Coyote Joe's Taco Cheese -- Shredded 2 Cheese Taco Blend -- Monterey Jack and Cheddar Cheeses with Taco Seasoning -- Net Wt 16 oz. -- UPC 41735 12509. Product is packaged in a plastic bag. Recall # F-0807-2012
CODE
Exp date April 21, 2012
RECALLING FIRM/MANUFACTURER
Recalling Firm: Price Chopper, Schenectady, NY, by press release on January 18, 2012.
Manufacturer: Great Lakes Cheese Co Inc., Hiram, OH. Firm initiated recall is complete.
REASON
The product has the possibility of containing shredded plastic fragments inside the packaging.
VOLUME OF PRODUCT IN COMMERCE
344 cases, 12 bags per case
DISTRIBUTION
NY, VT, CT, PA, MA, NH
The FDA begins a pilot program seeking to expedite notifications of human drug product recalls to the public. The agency will modify the drug product section of the Enforcement Report, published every Wednesday, to include actions that have been determined to be recalls, but that remain in the process of being classified as a Class I, II, or III action. Such recalls will be listed under the heading, “Recalls Pending Classification: DRUGS.” They will be reposted with their classification once that determination has been made. Send comments or suggestions to CDERRecallPilot@fda.hhs.gov.
RECALLS PENDING CLASSIFICATION: DRUGS
___________________________________
PRODUCT
1) 0.9% Sodium chloride Injection, USP, 250 mL, Rx only;
2) 1 g Lidocaine (4mg/mL), 250 mL, 0.4% Lidocaine HCl and 5% Dextrose Inj., USP, 250 mL
CODE
1) Lot# 94-833-KL, Exp. 10/12;
2) Lot# 92-643-KL, Exp. 02/12
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hospira Inc., Lake Forest, IL
Manufacturer: Hospira Inc., Rocky Mount, NC
REASON FOR RECALL
Superpotent
_____________________________________
PRODUCT
1) RegenArouse™ Natural Female Intimacy Enhancement, 1 capsule, Herbal Supplement
2) RegenErect™ Natural Male Enhancement, 1 capsule, Herbal Supplement
CODE
1) Lot Number 130100, Exp. 12/13
2) All lots packed in single capsule packet
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ethos Environmental Inc. dba Regeneca Inc.
Manufacturer: Ethos Environmental Inc. dba Regeneca Inc.
REASON FOR RECALL
Marketed Without an Approved NDA/ANDA: presence of tadalafil, the active ingredient found in a FDA approved drug to treat erectile dysfunction
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS I
___________________________________
PRODUCT
Excedrin Tension Headache (acetaminophen 500 mg, caffeine 65 mg) Caplets, packaged in a) 100-count bottles (NDC 0067-2045-91), b) 125-count bottles (NDC 0067-2045-84), c) 250-count bottles (NDC 0067-2045-07). Recall # D-1219-2012
CODE
Lot #: a) 10087530, Exp. 3/31/2013; b) 10089902, Exp. 4/30/2013; c) 10063947, Exp. 11/30/2011
RECALLING FIRM/MANUFACTURER
Novartis Consumer Health, Lincoln, NB, by letters on October 31, 2011 and press release on January 8, 2012. Firm initiated recall is ongoing.
REASON
Adulterated Presence of Foreign Tablets: Consumer complaints of foreign tablets reported in the products.
VOLUME OF PRODUCT IN COMMERCE
1,186,332 bottles (total for Recall # D-1219-2012 and Class II Recall # D-1220/D-1224-2012)
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Treanda (bendamustine HCL) for injection, 25mg/vial, Sterile-Single Use Vial, Rx Only, NDC 63459-0390-08. Recall # D-1254-2012
CODE
Lot #: TB30111, Exp 12/2012
RECALLING FIRM/MANUFACTURER
Recalling Firm: Cephalon, Inc., Malvern, PA, by letter on November 18, 2011 and press release on January 27, 2012.
Manufacturer: Pharmachemie B.V., Haarlem, Netherlands. Firm initiated recall is ongoing.
REASON
Presence of Particulate Matter; Glass fragments have been reported in a single vial.
VOLUME OF PRODUCT IN COMMERCE
21,592 Vials
DISTRIBUTION
Nationwide and Guam and Puerto Rico
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II
___________________________________
PRODUCT
Quelicin 1000, Succinylcholine Chloride, Inj., USP, 10mL single dose in 20mL Fliptop Vials, Rx only, NDC 0409-6970-10. Recall # D-1218-2012
CODE
Lot number: 02-575-EV
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hospira, Inc., Lake Forest, IL, by letter on January 17, 2012.
Manufacturer: Hospira, Inc., Rocky Mount, NC. Firm initiated recall is ongoing.
REASON
Labeling: Correct Labeled Product Mispacked; a vial of Lidocaine Hydrochloride 2% and Epinephrine 1:100,000 Injection, USP, 20 mL Fliptop Vial was found inside a 25 pack of Quelicin 1000.
VOLUME OF PRODUCT IN COMMERCE
9,650 vials
DISTRIBUTION
MS and TN
___________________________________
PRODUCT
1) Excedrin Extra Strength (acetaminophen 250 mg, aspirin 250 mg (NSAID), caffeine 65 mg) Tablets, packaged in a) 100-count bottles (NDC 0067-2030-91), b) 250-count bottles (NDC 0067-2030-77), and c) 300-count bottles (NDC 0067-2030-33). Recall # D-1220-2012;
2) Excedrin Extra Strength (acetaminophen 250 mg, aspirin 250 mg (NSAID), caffeine 65 mg) Express Gels gelcaps, packaged in 80-count Gelcaps per bottle, NDC 0067-6270-94. Recall # D-1221-2012;
3) Excedrin Migraine (acetaminophen 250 mg, aspirin 250 mg (NSAID), caffeine 65 mg) Caplets, packaged in 24-count bottles, NJ 07054-0622, NDC 0067-2039-24. Recall # D-1222-2012;
4) Excedrin Extra Strength (acetaminophen 250 mg, aspirin 250 mg (NSAID), caffeine 65 mg) Caplets, packaged in 24-count bottles, NJ 07054-0622, NDC 0067-2000-24. Recall # D-1223-2012;
5) Excedrin Migraine (acetaminophen 250 mg, aspirin 250 mg (NSAID), caffeine 65 mg) Tablets, packaged in 250-count bottles, NDC 0067-2037-77. Recall # D-1224-2012
CODE
1) Lot #: a) 10091817, Exp. 5/31/2013; b) 10092843, Exp. 6/30/2013; and c) 10073080, Exp. 6/30/2012;
2) Lot #10089353, Exp. 04/30/12;
3) Lot #: 10066070, 10066069, Exp. 1/31/2012; 10074660, Exp. 7/31/2012; 10101757, Exp. 10/31/2013; 10102541, Exp. 11/30/2013;
4) Lot #: 10085080, Exp. 1/31/2013;
5) Lot #: 10086758, Exp 2/28/2013; 10092845, Exp 6/30/2013
RECALLING FIRM/MANUFACTURER
Novartis Consumer Health, Lincoln, NB, by letters on October 31, 2011 and press release on January 8, 2012. Firm initiated recall is ongoing.
REASON
Adulterated Presence of Foreign Tablets: Consumer complaints of foreign tablets reported in the products.
VOLUME OF PRODUCT IN COMMERCE
1,186,332 bottles (total for Class I Recall # D-1219-2012 and Class II Recall # D-1220/D-1224-2012)
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Topiramate Tablets, 25 mg, a) NDC 0093-0155-10 (1000 count) and b) NDC 0093-0155-06 (60 count). Recall # D-1225-2012;
2) Topiramate Tablets, 200 mg, NDC 0093-7220-06 (60 count). Recall # D-1226-2012
CODE
1) a) Lot # 28T027, exp 1/2012; b) Lot # 28T030, exp 1/2012;
2) Lot # 16T020, exp 1/2012
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA, by letter on December 22, 2011.
Manufacturer: Teva Pharmaceutical Industries Ltd., Jerusalem, Israel. Firm initiated recall is ongoing.
REASON
Impurities/Degradation Products: High OOS results for Impurity.
VOLUME OF PRODUCT IN COMMERCE
82,653
DISTRIBUTION
Nationwide and PR
___________________________________
PRODUCT
1) Bufferin Extra Strength Buffered Aspirin (NSAID) (aspirin buffered with calcium carbonate, magnesium carbonate, and magnesium oxide) coated tablets, 500 mg, packaged in a) 39-ct. (NDC 0067-2065-39); and b) 130-ct. bottles (NDC 0067-2065-13). Recall # D-1227-2012;
2) Bufferin Buffered Aspirin (NSAID) Low Dose (aspirin buffered with calcium carbonate, magnesium carbonate, and magnesium oxide) coated tablets, 81 mg, 130-ct. bottles; NDC 0067-6424-13. Recall # D-1228-2012;
3) Bufferin Regular Strength Buffered Aspirin (NSAID) (aspirin buffered with calcium carbonate, magnesium carbonate, and magnesium oxide) coated tablets, 325 mg, 130-ct. bottles; NDC 0067-2063-13. Recall # D-1229-2012;
4) Excedrin Back & Body Extra Strength (acetaminophen 250 mg and aspirin 250 mg buffered with calcium carbonate) bi-layer caplets, packaged in a) 24-ct. bottles (NDC 0067-6238-24); b) 50-ct. bottles (NDC 0067-6238-50); and c) 100-ct. bottles (NDC 0067-6238-91 and NDC 0067-6238-94). Recall # D-1230-2012;
5) Excedrin Extra Strength (acetaminophen 250 mg, aspirin 250 mg, and caffeine 65 mg) caplets, packaged in a) 24-ct. bottles (NDC 0067-2000-24); b) 30-ct. (24-ct. + 6-ct. bonus) bottles (NDC 0067-2000-30); c) 50-ct. bottles (NDC 0067-2000-50); d) 100-ct. bottles (NDC 0067-2000-91 and NDC 0067-2000-94); e) 125-ct. (100-ct. + 25-ct. bonus) bottles (NDC 0067-2000-83, NDC 0067-2000-84, and NDC 0067-2000-86); f) 250-ct. bottles (NDC 0067-2000-07 and NDC 0067-2000-77); g) 300-ct. (250-ct. + 50-ct. bonus) bottles (NDC 0067-2000-55). Recall # D-1231-2012;
6) Excedrin Extra Strength (acetaminophen 250 mg, aspirin 250 mg, and caffeine 65 mg) Express Gels gelcaps, packaged in a) 20-ct. bottles (NDC 0067-6270-20); b) 40-ct. bottles (NDC 0067-6270-40); and c) 80-ct. bottles (NDC 0067-6270-80 and NDC 0067-6270-94). Recall # D-1232-2012;
7) Excedrin Extra Strength (acetaminophen 250 mg, aspirin 250 mg, and caffeine 65 mg) geltabs, 24-ct. bottles. Recall # D-1233-2012;
8) Excedrin Extra Strength (acetaminophen 250 mg, aspirin 250 mg, and caffeine 65 mg) tablets, packaged in a) 8-ct. bottles (NDC 0067-2030-08); b) 24-ct. bottles (NDC 0067-2030-24); c) 30-ct. bottles (24-ct. + 6-ct. bonus) (NDC 0067-2030-30); d) 50-ct. bottles (NDC 0067-2030-50); e) 100-ct. bottles (NDC 0067-2030-91 and NDC 0067-2030-94); f) 125-ct. bottles (100-ct + 25-ct. bonus) (NDC 0067-2030-83 and NDC 0067-2030-86); g) 200-ct. bottles (NDC 0067-2030-92); h) 250-ct. bottles (NDC 0067-2030-07 and NDC 0067-2030-77); i) 300-ct bottles (250-ct + 50-ct. bonus) (NDC 0067-2030-55 and NDC 0067-2030-57); j) 300-ct. bottles (NDC 0067-2030-33); k) 300-ct. club pack (3 x 100-ct. bottles) (UPC 3 0067 2423 33 7). Recall # D-1234-2012;
9) Excedrin Menstrual Complete Express Gels (acetaminophen 250 mg, aspirin 250 mg, and caffeine 65 mg) gelcaps, 20-ct. bottles; NDC 0067-6341-20. Recall # D-1235-2012;
10) Excedrin Migraine (acetaminophen 250 mg, aspirin 250 mg, and caffeine 65 mg) caplets, packaged in a) 8-ct. bottles (NDC 0067-2039-08); b) 24-ct. bottles (NDC 0067-2039-24); c) 30-ct. bottles (24-ct. + 6-ct. bonus) (NDC 0067-2039-30); d) 50-ct. (NDC 0067-2039-50); e) 100-ct. bottles (NDC 0067-2039-91 and NDC 0067-2039-94); f) 125-ct. bottles (100-ct + 25-ct. bonus) (NDC 0067-2039-84, NDC 0067-2039-86, and NDC 0067-2039-83); g) 200-ct. bottles (NDC 0067-2039-92); h) 250-ct. bottles (200-ct. + 50-ct. bonus) (NDC 0067-2039-55 and 0067-2039-57); i) 250-ct. bottles (NDC 0067-2039-07 and NDC 0067-2039-77); j) 300-ct. bottles (NDC 0067-2039-33); k) 300-ct. club pack (3 x 100-ct. bottles) (UPC 3 0067 2424 33 4). Recall # D-1236-2012;
11) Excedrin Migraine (acetaminophen 250 mg, aspirin 250 mg, and caffeine 65 mg) geltabs, packaged in a) 24-ct. bottles (NDC 0067-2035-24); b) 50-ct. bottles (NDC 0067-2035-50); c) 100-ct. Twin Pack carton containing [2 x 50-ct. bottles (NDC 0067-2035-50)] (carton NDC 0067-2035-91 and 0067-2035-93); d) 160-ct. Twin Pack carton containing [2 x 80-ct. bottles (NDC 0067-2035-80)] (carton NDC 0067-2035-16). Recall # D-1237-2012;
12) Excedrin Migraine (acetaminophen 250 mg, aspirin 250 mg, and caffeine 65 mg) tablets, packaged in a) 24-ct. bottle (NDC 0067-2037-24); b) 30-ct. bottle (24-ct. + 6-ct. bonus) (NDC 0067-2037-30); c) 50-ct. bottle (NDC 0067-2037-50); d) 100-ct. bottle (NDC 0067-2037-91; e) 125-ct. bottle (100-ct. + 25-ct. bonus) (NDC 0067-2037-83; f) 250-ct. bottle (NDC 0067-2037-77). Recall # D-1238-2012;
13) Excedrin PM (acetaminophen 500 mg and diphenhydramine citrate 38 mg) caplets, packaged in a) 24-ct. bottles (NDC 0067-2055-24); b) 50-ct. bottles (NDC 0067-2055-50); c) 100-ct. bottles (NDC 0067-2055-91); and d) 125-ct. bottles (100-ct. + 25-ct. bonus) (NDC 0067-2055-86). Recall # D-1239-2012;
14) Excedrin PM (acetaminophen 500 mg and diphenhydramine citrate 38 mg) Express Gels gelcaps, packaged in a) 20-ct. bottles (NDC 0067-6405-20); and b) 80-ct. bottles (NDC 0067-6405-80 and NDC 0067-6409-80). Recall # D-1240-2012;
15) Excedrin PM (acetaminophen 500 mg and diphenhydramine citrate 38 mg) tablets, packaged in a) 8-ct. bottles (NDC 0067-2053-08); b) 24-ct. bottles (NDC 0067-2053-24); c) 30-ct. bottles (24-ct. + 6-ct. bonus) (NDC 0067-2053-30); d) 50-ct. bottles (NDC 0067-2053-50); e) 100-ct. bottles (NDC 0067-2053-91 and NDC 0067-2053-94); f) 125-ct. (100-ct. + 25-ct. bonus) (NDC 0067-2053-83). Recall # D-1241-2012;
16) Excedrin Sinus Headache (acetaminophen 325 mg and phenylephrine HCl 5 mg) caplets, 24-ct. bottles; NDC 0067-2062-24. Recall # D-1242-2012;
17) Excedrin Tension Headache (acetaminophen 500 mg and caffeine 65 mg) caplets, packaged in a) 24-ct. bottles (NDC 0067-2045-24); b) 30-ct. (24-ct. + 6-ct. bonus) (NDC 0067-2045-30); c) 50-ct. bottles (NDC 0067-2045-50); d) 100-ct. bottles (NDC 0067-2045-91 and NDC 0067-2045-94); e) 125-ct. bottles (100-ct. + 25-ct. bonus) (NDC 0067-2045-83 and NDC 0067-2045-84); and f) 250-ct. bottles (NDC 0067-2045-77 and NDC 0067-2045-07). Recall # D-1243-2012;
18) Excedrin Tension Headache (acetaminophen 500 mg and caffeine 65 mg) Express Gels gelcaps, packaged in a) 20-ct. bottles (NDC 0067-6272-20); b) 40-ct. bottles (NDC 0067-6272-40); and c) 80-ct. bottles (NDC 0067-6272-94). Recall # D-1244-2012;
19) Excedrin Tension Headache (acetaminophen 500 mg and caffeine 65 mg) geltabs, 24-ct. bottles; NDC 0067-2050-24. Recall # D-1245-2012;
20) Gas-X Prevention [alpha-galactosidase enzyme (aspergillus niger)] capsules, 600 GALU, packaged in a) 20-ct. bottles (UPC 30043-3005-208) and b) 50-ct. bottles (UPC 30043-3005-505). Recall # D-1246-2012;
21) Maximum Strength NoDoz (caffeine) coated caplets, 200 mg, packaged in a) 16-ct. bottles (NDC 0067-2070-16); b) 36-ct. bottles (NDC 0067-2070-36); and c) 60-ct. bottles (NDC 0067-2070-60). Recall # D-1247-2012
CODE
All lots that bear expiration date of 12/20/13 or earlier and all lots that bear expiration date of 12/20/14 or earlier.
RECALLING FIRM/MANUFACTURER
Novartis Consumer Health, Lincoln, NB, by press release, telephone and letters on January 8, 2012 and letters on January 9, 2012. Firm initiated recall is ongoing.
REASON
CGMP Deviations: Potential for the bottles to contain foreign tablets or broken/chipped tablets; lack of cGMP's.
VOLUME OF PRODUCT IN COMMERCE
123,991,832 bottles
DISTRIBUTION
Nationwide, and Internationally
___________________________________
PRODUCT
1) Cefprozil Powder for Oral Suspension, USP 125 mg/5 mL when constituted according to direction, Rx only, 100 mL. NDC: 00781-6202-46. Recall # D-1249-2012
2) Cefprozil Powder for Oral Suspension, USP 250 mg/5 mL when constituted according to direction, Rx only, 100 mL. NDC: 00781-6203-46. Recall # D-1250-2012
CODE
1) Lots BX3481 and BX3483 and 2) Lot: BX3670
RECALLING FIRM/MANUFACTURER
Recalling Firm: Sandoz Inc., Broomfield, CO, by letter dated January 2012.
Manufacturer: Sandoz GmbH, Kundl, Austria. Firm initiated recall is ongoing.
REASON
CGMP Deviations: Batches lack manufacturing validation.
VOLUME OF PRODUCT IN COMMERCE
2,024 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Ventolin HFA (albuterol sulfate) 90 mcg per actuation a) 60 Actuations, NDC 0173-0682-21; b) 60 Actuations Sample, NDC 0173-0682-23; c) 60 Actuations Institutional Pack, NDC 0173-0682-24 Rx only. Recall # D-1252-2012;
2) Ventolin HFA Inhaler (albuterol sulfate) 90 mcg per actuation NOVAPLUS - 60 Actuations, Rx only, NDC 0173-0682-54. Recall # D-1253-2012
CODE
1) Lot: 1ZP0922, 1ZP0571, 1ZP6915, 1ZP6939, 1ZP7823, 1ZP8151, 1ZP0856, 1ZP1981, 1ZP6941, 1ZP7824, 1ZP9063;
2)Lot numbers: 1ZP1061, 1ZP6940 and 1ZP9680
RECALLING FIRM/MANUFACTURER
GlaxoSmithKline Inc., Zebulon, NC, via letter on/about January 18, 2012. Firm initiated recall is ongoing.
REASON
Does Not Deliver Proper Metered Dose: The affected canisters may not contain sufficient propellant to deliver the labeled claim of 60 doses.
VOLUME OF PRODUCT IN COMMERCE
886,620 inhalers
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Cytarabine for Injection USP, for Intravenous, Subcutaneous, or Intrathecal use, 1 gram, Rx Only, NDC 55390-133-01. Recall # D-1255-2012
CODE
Lot #: 2066986, Exp 03/31/2014; 2111675, Exp 04/30/2014; 2131148, Exp 05/31/2014
RECALLING FIRM/MANUFACTURER
Ben Venue Laboratories Inc., Bedford, OH, by letter on February 15, 2012, a press release on February 16, 2012 and a follow-up letter on February 17, 2012. Firm initiated recall is ongoing.
REASON
Lack of Assurance of Sterility
VOLUME OF PRODUCT IN COMMERCE
19,628 Vials
DISTRIBUTION
Nationwide
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III
___________________________________
PRODUCT
Bupropion Hydrochloride Extended-Release Tablets (XL), 150mg tablets,150mg, packaged in 10-count UD tablets (NDC #68084-251-11), 10 x 10-count tablets per box (NDC 68084-251-01) Rx only, Recall # D-1248-2012
CODE
AHP Lot 110564, Exp. Date 03/31/2012; AHP Lot 103077, Exp. Date 03/31/2012; AHP Lot 103499, Exp. Date 06/30/2012 & AHP Lot 110450, Exp. Date 03/31/2012
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Health Packaging, Columbus, OH, by letters on January 18, 2912.
Manufacturers: Actavis South Atlantic LLC. Sunrise, FL;
CMIC CMO USA Corp., Cranbury, NJ. Firm initiated recall is ongoing.
REASON
Failed USP Dissolution Requirements: American Health Packaging was notified by their supplier that the product is being recalled due to possible out-of-specification dissolution results for 8-hours stability testing point.
VOLUME OF PRODUCT IN COMMERCE
3,797 boxes
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Azelastine Hydrochloride Ophthalmic Solution, 0.05% 6 mL-Sterile, For the Eye Only, Rx only, NDC 47335-938-90. Recall # D-1251-2012
CODE
Lots: JKJl389A, JKJ1514A JKJ1515A. JKJ2541A, JKJ2542A, JKJ2646A, JKJ3050A, JKJ3425A, JKJ3126A, JKK0817A, JKK0884A, JKK0885A, JKJ2187A, JKK2268A, JKK2269A, JKK2315A, JKK2472A, JKK2473A
RECALLING FIRM/MANUFACTURER
Sun Pharmaceutical Industries Ltd., Halol, India, by letters and telephone beginning February 6, 2012. Firm initiated recall is ongoing.
REASON
Impurities/Degradation Products: The total impurities results were out of specification (OOS) during the analysis of 18 month controlled stability sample.
VOLUME OF PRODUCT IN COMMERCE
155,363 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-0530-12
CODE
Unit: W141608194114
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood Center, Seattle, WA, by letter dated July 17, 2008.
Manufacturer: Puget Sound Blood Center and Program, Silverdale, WA. Firm initiated recall is complete.
REASON
Blood product, collected using an expired arm scrub reagent, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WA
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-0532-12;
2) Plasma Frozen. Recall # B-0533-12
CODE
1) Units: 20FM44281; 20FM48241;
2) Unit: 20FM44281
RECALLING FIRM/MANUFACTURER
Recalling Firm: American National Red Cross, Lewis and Clark Region, Salt Lake City, UT, by fax and electronically on May 15, 2008.
Manufacturer: American National Red Cross, Missoula, MT. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
MT, CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0537-12
CODE
Unit: W141608194425
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood Center, Seattle, WA, by letter dated July 17, 2008.
Manufacturer: Puget Sound Blood Center and Program, Silverdale, WA. Firm initiated recall is complete.
REASON
Blood product, collected using an expired arm scrub reagent, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0538-12
CODE
Unit: 221063449
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Las Vegas, NV, by telephone on July 1, 2005. Firm initiated recall is complete.
REASON
Blood product, which was untested for viral markers, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-0539-12
CODE
Units: W068508369837A; W068508369837B; W068508369817A; W068508369817B
RECALLING FIRM/MANUFACTURER
Inland Northwest Blood Center, Spokane, WA, by letter dated December 8, 2008. Firm initiated recall is complete.
REASON
Blood products, collected using apheresis equipment for which there was no documentation of daily QC, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
WA
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-0596-12;
2) Platelets Pooled Leukocytes Reduced Irradiated. Recall # B-0597-12;
3) Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-0598-12
CODE
1) Unit: W141608009129;
2) and 3) Unit: W141608004731
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood Center and Program, Seattle, WA, by letter dated October 9, 2008.
Manufacturer: Puget Sound Blood Center and Program, Bellevue, WA. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
WA
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-0643-12;
2) Plasma Frozen. Recall # B-0644-12
CODE
1) Units: 20LE18152; 20LE18146; 20LE18141; 20LE18119; 20LE18125; 20LE18134;
2) Units: 20LE18130; 20LE18141
RECALLING FIRM/MANUFACTURER
American National Red Cross, Boise, ID, by fax and letter on June 19, 2008. Firm initiated recall is complete.
REASON
Blood products, collected in a manner that may have compromised the sterility of the units, were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units
DISTRIBUTION
ID, UT
___________________________________
PRODUCT
1) Recovered plasma. Recall # B-0646-12;
2) Red Blood Cells Leukocytes Reduced. Recall # B-0647-12;
3) Cryoprecipitated AHF. Recall # B-0648-12
CODE
1); 2) and 3) Unit: W333610077128
RECALLING FIRM/MANUFACTURER
Mississippi Valley Regional Blood Center, Davenport, IA, by Electronic Delivery Notification on November 18, 2011 and letter dated November 23, 2011. Firm initiated recall is complete.
REASON
Donor Screening/Donor gave history which warranted deferral or follow up and was not deferred or follow up questions were not asked.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
Switzerland; NJ
___________________________________
PRODUCT
1) Red Blood Cells. Recall # B-0654-12;
2) Fresh Frozen Plasma. Recall # B-0655-12;
3) Red Blood Cells Leukocytes Reduced. Recall # B-0656-12;
4) Red Blood Cells Leukocytes Reduced, Irradiated. Recall # B-0657-12;
5) Fresh Frozen Plasma Irradiated. Recall # B-0658-12
CODE
1) Unit: LM67493;
2) Unit: LM83682;
3) LM32253, LM32283, LM32330, LM55272, LM63545, LM67174, LM67222, LM73230, LM74795, LM75018, LM76629, LM86332, LM91251, LM32256, LM32395, LM32416, LM55255, LM55290, LM55310, LM63506, LM63553, LM66035, LM66043, LM66062, LM67172, LM67216, LM67494, LM71929, LM71942, LM74756, LM74785, LM75005, LM75036, LM76631, LM78466, LM86307, LM87130, LM87142, LM87225, LM91255, LM91296, LM32266, LM32349, LM32373, LM66047, LM66570, LM66597, LM67187, LM75058, LM78484, LM86818, LM32277, LM32306, LM55338, LM63552, LM66054, LM67167, LM67396, LM67405, LM67477, LM67779, LM71909, LM71936, LM72589, LM72620, LM73168, LM73172, LM73211, LM78448, LM87150, LM87152, LM87179, LM87213, LM67761, LM32304, LM32397, LM63567, LM66738, LM71931, LM72634, LM78474, LM83686, LM32309, LM32323, LM32335, LM32343, LM32417, LM67168, LM67416, LM67465, LM67825, LM71939, LM71946, LM71948, LM72597, LM72652, LM73221, LM74783, LM74818, LM83682, LM83687, LM32334, LM63564, LM67190, LM67193, LM78498, LM32362, LM75043, LM66067, LM32368, LM32427, LM67184, LM55265, LM55278, LM67178, LM67212, LM67214, LM55318, LM87132, LM55337, LM67801, LM86302, LM91298, LM62721, LM63549, LM66051, LM66606, LM67400, LM67481, LM67785, LM74789, LM87163, LM87169, LM62723, LM86274, LM63510, LM72625, LM74529, LM75038, LM63540, LM87215, LM87232, LM63542, LM66056, LM66559, LM74755, LM86322, LM87188, LM63562, LM67837, LM67851, LM74554, LM66041, LM66735, LM66737, LM72643, LM73198, LM74532, LM78459, LM66554, LM67160, LM67164, LM87194, LM87223, LM87242, LM67217, LM67226, LM67227, LM67409, LM73171, LM86827, LM91290, LM67228, LM72587, LM78473, LM78486, LM86283, LM86336, LM86816, LM73196, LM83689, LM71930, LM67816, LM71955, LM72584, LM72650, LM73184, LM73215, LM74759, LM74803, LM87206, LM67753, LM72593, LM72602, LM74794, LM72661, LM86335, LM91280, LM87176, LM87201, LM67181 (parts 1, 2, & 3);
4) LM66578, LM67455, LM67463, LM66566, LM66587 (parts 1, 2, 3, 4, 5, 6, 7, & 8), LM73210, LM72646, LM74805, LM74772;
5) LM55290 (parts 1, 2, & 3)
RECALLING FIRM/MANUFACTURER
Sacramento Medical Foundation, Sacramento, CA, by telephone and facsimile on November 1, 2006. Firm initiated recall is complete.
REASON
Blood products, collected in a manner that may have compromised the sterility of the units, were distributed.
VOLUME OF PRODUCT IN COMMERCE
224 units
DISTRIBUTION
CA
___________________________________
PRODUCT
1) Cryoprecipitated AHF. Recall # B-0660-12;
2) Red Blood Cells (Apheresis) Leukocytes Reduced Irradiated. Recall # B-0661-12;
3) Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-0662-12;
4) Fresh Plasma Frozen. B-0663-12;
5) Red Blood Cells Leukocytes Reduced. Recall # Recall # B-0664-12
CODE
1) Units: 19263-5406, 19263-5561, 19263-8139, 19263-8142, 19263-8144, 19263-8194;
2) Units: 19263-0000, 19263-0000, 19263-6948;
3) Units: 19262-7096, 19262-7102, 19262-7159, 19262-7160, 19262-7192, 19262-7193, 19263-0002, 19263-0014, 19263-0040, 19263-0043, 19263-0619, 19263-0621, 19263-0631, 19263-0633, 19263-0635, 19263-5505, 19263-6693, 19262-7096, 19262-7102, 19262-7159, 19262-7160, 19262-7192, 19262-7193, 19263-0002, 19263-0014, 19263-0040, 19263-0043, 19263-0619, 19263-0621, 19263-0631, 19263-0633, 19263-0635, 19263-0691, 19263-5505, 19263-6693;
4) Units: 19263-5506, 19263-5510, 19263-8116;
5) Units: 19263-5406, 19263-5506, 19263-5509, 19263-5510, 19263-5511, 19263-5512, 19263-5513, 19263-5514, 19263-5515, 19263-5516, 19263-5518, 19263-5561, 19263-6073, 19263-6095, 19263-8116, 19263-8119, 19263-8139, 19263-8142, 19263-8144, 19263-8170, 19263-8194
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Reno, NV, by telephone on February 9 and 10, 2006 or by e-mail on March 16 and 20, 2006. Firm initiated recall is complete.
REASON
Blood products, collected in a manner that may have compromised the sterility of the units, were distributed.
VOLUME OF PRODUCT IN COMMERCE
68 units
DISTRIBUTION
CA, AZ, NV
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0666-12
CODE
Unit: 018FY99327
REC American National Red Cross Great Lakes Region, Lansing, MI, by telephone and fax on November 25, 2011 and follow up fax on December 28, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported post donation illness, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MI
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0668-12
CODE
Units: W158011702825; W158011702825
RECALLING FIRM/MANUFACTURER
Arup Laboratories, Inc., Sandy, UT, by telephone and e-mail on December 12, 2011. Firm initiated recall is complete.
REASON
Blood products, which were labeled as leukoreduced, but did not meet the requirements for leukoreduced products, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
UT
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0672-12
CODE
Unit: W04101110823500
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc dba United Blood Services, Scottsdale, AZ, by letter dated November 30, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland
___________________________________
PRODUCT
1) Platelets Pheresis Leukocytes Reduced. Recall #: B-0681-12;
2) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-0682-12
CODE
1) Unit: 21KP76313 (1); 21KP76313 (2);
2) Unit: 21KP76314
RECALLING FIRM/MANUFACTURER
American National Red Cross, Portland, OR, by telephone on November 28, 2005 and follow-up letter dated March 13, 2006, and by telephone on December 30, 2005 and follow-up letter dated January 4, 2006. Firm initiated recall is complete.
REASON
Blood products, mislabeled as having been tested for HIV and HCV by NAT, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
WA, OR, CA
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0684-12
CODE
Unit: V69610
RECALLING FIRM/MANUFACTURER
Tacoma Pierce County Blood Bank, Tacoma, WA, by electronic notification on November 1, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0685-12
Units: W141607251187; W141607250450; W141607040283; W141606390615; C343639; P154460; L172508; P144526
RECALLING FIRM/MANUFACTURER
Puget Sound Blood Center and Program, Seattle, WA, electronically on December 31, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units
DISTRIBUTION
Austria
___________________________________
PRODUCT
Red Blood Cells. Recall # B-0687-12
CODE
Unit: W036810214188
RECALLING FIRM/MANUFACTURER
Community Blood Centers of Florida, Inc., Lauderhill, FL, by telephone and letter on September 29, 2011.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland; FL
___________________________________
PRODUCT
Red Blood Cells. Recall # B-0688-12
CODE
Unit: W036811076584
RECALLING FIRM/MANUFACTURER
Community Blood Centers of South FL, Inc., Orlando, FL, by telephone and follow up letter on December 1, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0689-12
CODE
Units: W1151112719984; W1151112719984
RECALLING FIRM/MANUFACTURER
Lifesouth Community Blood Centers, Inc., Mobile, AL, by fax on November 17, 2011. Firm initiated recall is complete.
REASON
Blood products, labeled as leukoreduced without the assurance they met the requirements for leukoreduced products, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
AL
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-0690-12;
2) Plasma Frozen. Recall # B-0691-12
CODE
1) and 2) Unit: W117011504491
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Centers of the Pacific - Irwin Center, San Francisco, CA, by telephone on December 6, 2011 and letter dated December 13, 2011.
Manufacturer: Blood Centers of the Pacific - Santa Rosa Center, Santa Rosa, CA, Firm initiated recall is complete.
REASON
Blood products, collected from a donor who received a body piercing within 12 months of donating, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Source Plasma. Recall # B-0692-12
CODE
Units: 10PWIH0903; 10PWIE5170; 09PWIJ8774
RECALLING FIRM/MANUFACTURER
Biolife Plasma Services, Stevens Point, WI, electronically on November 8, 2011. Firm initiated recall is complete
REASON
Blood products, collected from a donor whose physical examination was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
Austria
___________________________________
PRODUCT
1) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-0710-12;
2) Platelets Pheresis Leukocytes Reduced. Recall # B-0711-12
CODE
1) Units: LJ30698, LJ32651;
2) Units: LJ30698, LJ33272
RECALLING FIRM/MANUFACTURER
Blood Bank of the Redwoods, Santa Rosa, CA, by letter on June 24, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor due to use of the drug dutasteride, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0732-12
CODE
Unit: W041611024376E
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems Inc/dba United Blood Services, Meridian, MS, by letters dated December 19, 2011 and January 19, 2010.
Manufacturer: Blood Systems Inc/dba United Blood Services, Hattiesburg, MS. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MS
___________________________________
PRODUCT
1) Fresh Frozen Plasma. Recall # B-0733-12;
2) Red Blood Cells. Recall # B-0734-12
CODE
1) and 2) Unit: W036811274964
RECALLING FIRM/MANUFACTURER
Community Blood Centers of South Florida, Inc., Lake Worth, FL, by telephone on January 16, 2012. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL, NY
___________________________________
PRODUCT
Red Blood Cells. Recall # B-0735-12
CODE
Unit: 2541589
RECALLING FIRM/MANUFACTURER
Community Blood Centers of Florida, Inc., Miami, FL, by telephone and follow up letter on January 11, 2012. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
1) Red Blood Cells. Recall # B-0736-12;
2) Fresh Frozen Plasma. Recall # B-0737-12;
3) Platelets Pooled Leukocytes Reduced. Recall # B-0738-12
CODE
1) and 2) Unit: W036811211940;
3) Unit: W036811819963
RECALLING FIRM/MANUFACTURER
Community Blood Centers of Florida, Inc., Lauderhill, FL, by telephone and follow up letter on January 11, 2012. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
FL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0739-12
CODE
Unit: W0411110596790
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc. dba United Blood Services, El Paso, TX, by telephone on January 19, 2012. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
___________________________________
PRODUCT
1) Recovered Plasma. Recall # B-0766-12;
2) Cryoprecipitated AHF, Pooled. Recall # B-0767-12
CODE
1) Unit: W038111093452;
2) Unit: W038111982342
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers, Inc., Orlando, FL, by telephone on December 7, 2011 and by letter dated December 8, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III
___________________________________
PRODUCT
Recovered Plasma, Recall # B-0422-12
CODE
Unit: 36FW17072
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Columbia, SC, via the LOGIC system on October 28, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
SC
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0531-12
CODE
Unit: 20FM48241
RECALLING FIRM/MANUFACTURER
Recalling Firm: American National Red Cross, Lewis and Clark Region, Salt Lake City, UT, by fax and electronically on May 15, 2008.
Manufacturer: American National Red Cross, Missoula, MT. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MT, CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0534-12
CODE
Unit: 3228651
RECALLING FIRM/MANUFACTURER
Northern California Community Blood Bank, Eureka, CA, by telephone and fax on July 24, 2008. Firm initiated recall is complete.
REASON
Blood product, manufactured without the entire amount of Optisol added during component preparation, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0540-12
CODE
Unit: 004Z68510
RECALLING FIRM/MANUFACTURER
Recalling Firm: Arc Blood Services, New England Region, Dedham, MA, by e-mail on November 10, 2011.
Manufacturer: ARC/North Shore Donor Center, Danvers, MA. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells. Recall # B-0645-12
CODE
Unit: W051510118708
RECALLING FIRM/MANUFACTURER
Recalling Firm: Memorial Blood Centers, Saint Paul, MN, by letters dated November 4, 2011 and December 13, 2011.
Manufacturer: Memorial Blood Centers – Duluth, Duluth, MN. Firm initiated recall is complete.
REASON
Blood product, collected from a donor with an elevated temperature, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MN
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-0665-12
CODE
Units: UW044611326779; W044611326779
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by fax on September 30, 2011, October 4, 2011 and October 6, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose arm inspection was not documented, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 Units
DISTRIBUTION
TX
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0667-12
CODE
Unit: 021LV61160
RECALLING FIRM/MANUFACTURER
American National Red Cross, Portland, OR, electronically on November 1 and November 10, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-0669-12
CODE
Units: W1151120245884; W1151120245884
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Brooksville, FL, by fax on November 25, 2011. Firm initiated recall is complete.
REASON
Blood products, with unacceptably low red cell recovery rates, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0686-12
CODE
Unit: W036810214188
RECALLING FIRM/MANUFACTURER
Community Blood Centers of Florida, Inc., Lauderhill, FL, by telephone and letter on September 29, 2011.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland; FL
___________________________________
PRODUCT
Standardized Bermuda Grass pollen. Recall # B-0712-12
CODE
Unit: B29041310 (mislabeled as B39041310)
RECALLING FIRM/MANUFACTURER
Antigen Laboratories Inc., Liberty, MO, by telephone on August 30, 2010 or August 31, 2010. Firm initiated recall is complete.
REASON
Allergenic extract, misbranded with an incorrect lot number, was distributed.
VOLUME OF PRODUCT IN COMMERCE
Six - 30ml vials
DISTRIBUTION
TX, OH, IL
RECALLS AND FIELD CORRECTIONS: DEVICES – CLASS II
___________________________________
PRODUCT
1) Arm and Hammer Spinbrush Dual Action Powered Toothbrush Pro-Clean, various models. Made in China. For dental health; plaque removal. a) Spinbrush Pro Clean Soft; b) Spinbrush Pro Clean Medium; c) Spinbrush Pro Clean Replacement Head Soft 2 ct; d) Spinbrush Pro Clean Replacement Head Medium 2 ct; e) Spinbrush Pro Clean 3 ct BJs; f) Spinbrush Pro Clean 2 ct; g)Spinbrush Pro Clean Extra Soft 2 ct; h) Spinbrush Pro Clean Combo Pack; i) Spinbrush Pro Clean Value Pack; j) Spinbrush Pro Clean Soft Value Pack; k) Total Spinbrush Pro Clean Spinbrush Pro Recharge Spinbrush Pro Clean Recharge. Total Spinbrush Recall # Z-0857-2012
2) Arm and Hammer Spinbrush Dual Action Powered Toothbrush Pro Clean Re-Charge Made in China. For dental health; plaque removal. Recall # Z-0858-2012;
3) Arm and Hammer Spinbrush Dual Action Powered Toothbrush Spinbrush Pro Whitening Made in China. For dental health; plaque removal. a) Spinbrush Pro Whitening Soft; b) Spinbrush Pro Whitening Replacement Head Soft 2 ct; c) Spinbrush Pro Whitening Medium; d) Spinbrush Pro Whitening Replacement Head Medium 2 ct. Recall # Z-0859-2012
CODE
1) a) 6687800078; b) 6687800079; c) 6687800080; d) 6687800081; e) 6687800145; f) 6687800425; g) 6687800433; h) 6687800461; i) 6687800466; j) 6687800709; k) 6687800160;
2) 6687800160;
3) a) 6687800191; b) 6687800192; c) 6687800193; d) 6687800194
RECALLING FIRM/MANUFACTURER
Church & Dwight Inc., Princeton. NJ, by a Safety Notice starting on December 22, 2011. Firm initiated recall is ongoing.
REASON
Church and Dwight plans to take actions to best convey to the public the potential small parts choking hazard with using a Spinbrush beyond the recommended 3-month brush head life.
VOLUME OF PRODUCT IN COMMERCE
39.103 million units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
1) Presource Custom Sterile Surgical and Procedure Kits; general surgery trays; The kit catalog numbers: SBA48UMCHF, SMA21CIDCB, SMA21CRDCC, SMA21CRDCD, SRHHFCIMM1, SRHHFCIMM2, SRHHFCIMMA and SRHHFCIMMB contain one or more of the following listed components: a) Jobri Circumcision Strap, Small, 2 x 8 inch, component part number 086-0001; b) Jobri Circumcision Strap, Large, 2 x 10 inch, component part number 086-0002; The restraint is used to secure an infant during a circumcision procedure. Product Usage: The kits are custom packed with all of the specific disposable class 1 and 2 devices required by the customer for specific types of surgery and medical procedures. These packs are then sterilized and are ready to be used by the customer for the specific procedure. The restraint is used to secure an infant during a circumcision procedure. Recall # Z-0925-2012;
2) Presource Custom Sterile Surgical and Procedure Kits; surgical trays; The kit catalog numbers: 02-0114C, 02-0336, 02-0619, 02-0790A, 02-1502B, 02-1880, 02-2064, 02-2843A, 02-3022A, 02-3867I, 02-3867J, 02-4716C, 02-7483, 02A0790A, 02B0790, 10-0023C, 10-0059A, 10-0078, 10-0079B, 10-0089, 10-1077B, 10-2637C, 10-3050C, NI10-0007B, NI10-0020H, NI10-0039, NI10-0073B, NI10-0083, NI10-5406, NI10-7799D, NI10-8184A and NI12-1714 contain one or more of the following listed components: a) Jobri Circumcision Strap, Small, 2 x 8 inch, component part number 086-0001; b) Jobri Circumcision Strap, Large, 2 x 10 inch, component part number 086-0002; The restraint is used to secure an infant during a circumcision procedure. Product Usage: The kits are custom packed with all of the specific disposable class 1 and 2 devices required by the customer for specific types of surgery and medical procedures. These packs are then sterilized and are ready to be used by the customer for the specific procedure. The restraint is used to secure an infant during a circumcision procedure. Recall # Z-0926-2012
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Cardinal Health, McGaw Park, IL, by letter dated December 23, 2011.
Manufacturer: Cardinal Health, McGaw Park, IL;
Jobri, LLC, Konawa, OK. Firm initiated recall is ongoing.
REASON
The Presource kits were assembled with a Jobri Infant Restraint Strap which does not have the appropriate 510(k) pre-market clearance.
VOLUME OF PRODUCT IN COMMERCE
15,369 kits
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
REF C9944A***"FULL RADIUS RESECTOR"***2.9mm***Qty 6***STERLING***STERILE***Rx Only. *** Made in the USA***. Soft Tissue resection and removal. Recall # Z-0987-2012
CODE
Lot # 95987
RECALLING FIRM/MANUFACTURER
Linvatec Corp. dba ConMed Linvatec, Largo, FL, by telephone on November 12, 2009. Firm initiated recall is ongoing.
REASON
There was a possibility that the device was assembled with an incorrect outer tube.
VOLUME OF PRODUCT IN COMMERCE
30 units
DISTRIBUTION
GA, NY
___________________________________
PRODUCT
BD 30G1/2" Precision Glide" Needle. Needles are used for aspiration and injection of medications. Marketing Status: K021475; Device Listing #: DQ41418; Reorder # 300745. Recall # Z-1009-2012
CODE
Lot # lll6090
RECALLING FIRM/MANUFACTURER
Recalling Firm:Becton Dickinson & Co., Franklin Lakes, NJ, by letters dated October 18, 2011 and October 17, 2011.
Manufacturer: BD Medical Surgical, Columbus, NB. Firm initiated recall is ongoing.
REASON
Becton Dickinson has identified clogged needles.
VOLUME OF PRODUCT IN COMMERCE
480,000 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Model #03001-02: Periophil Biphasic, Synthetic Biphasic Dental Bone Graft Granules, 1.0 cc. 2) Model # 03003-01 Periobase Biphasic: Periobase, Synthetic Biphasic Dental Bone Biphasic Granules, 0.5 cc. 3) Model #03002-01: Periobone Biphasic, Synthetic HA/TCP Dental Bone Graft Biphasic Granules, 0.5 cc. Periophil Biphasic (synthetic grafting material) is intended for use as a bone grafting material to fill, augment, or reconstruct periodontal or oral/maxillofacial defects. Recall # Z-1012-2012
CODE
1) a) Lot # Z13-927A, expiration date 2/1/2014; b) Lot # Z13-927B, expiration date 2/1/2014; c) Lot # Z13-926A, expiration date 2/1/2014; d) Lot # N13-925C, expiration date 1/31/2014;
2) Lot # N13-925B, expiration date 1/31/2014;
3) Lot # N13-925A, expiration date 1/31/2012
RECALLING FIRM/MANUFACTURER
Recalling Firm: Cytophil, Inc., East Troy, WI, by letter dated January 11, 2012.
Manufacturer: Cytophil, Inc., East Troy, WI;
Steris Isomedix Services, Libertyville, IL. Firm initiated recall is ongoing.
REASON
Product recalled because devices were inadvertently shipped after receiving an inadequate dose of radiation and this product may not be sterile.
VOLUME OF PRODUCT IN COMMERCE
547 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Orthofix rotating cutter used in spinal fusion procedures with the FORZA Spacer System. a) Catalog Number 89-0452 (8mm Rotating Cutter), 89-0454 (10mm Rotating Cutter), and 89-0030 (FORZA Discectomy Case). Manual surgical instrument comprised of stainless steel and titanium. Recall # Z-1037-2012
CODE
a) Lot Numbers; 33056-ND25 and 33056-NE19;
b) Lot Numbers: 33056-ND26 and 33056-NF02
RECALLING FIRM/MANUFACTURER
Orthofix, Inc., Lewisville, TX, by letters on February 6, 2012. Firm initiated recall is ongoing.
REASON
The 8mm and 10mm Rotating Cutters may fracture during use, specifically during disc space preparation. If an 8mm or 10mm Rotating Cutter does Fracture during use, it may result in a surgical delay estimated to be 30 minutes or greater due to preparing the disc space using other instruments or methods and/or retrieving the instrument fragment.
VOLUME OF PRODUCT IN COMMERCE
26 units of the 8mm Rotating Cutter and 26 units of the 10mm Rotating Cutter
DISTRIBUTION
Nationwide and PR
___________________________________
PRODUCT
1) Leica Bond Ready-to-Use Primary Antibody CD2 (11F11); 7 mL vial; an in vitro diagnostic primary antibody for use as part of an antibody panel for the characterization of T cell disorders; Catalog No. PA0271. For the qualitative identification by light microscopy of human CD2 molecule in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated Bond system. Recall # Z-1052-2012;
2) Leica Bond Ready-to-Use Primary Antibody CD7 (LP15) Reagent; 7 mL vial; an in vitro diagnostic monoclonal antibody for use as part of an antibody panel for the classification of tumors of T-cell origin; Catalog No. PA0266; For the qualitative identification by light microscopy of CD7 molecule in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated Bond system. Recall # Z-1053-2012;
3) Novocastra Liquid Concentrated Mouse Monoclonal Antibody CD7 (LP15) Reagent; an in vitro diagnostic primary antibody for use as part of an antibody panel for the classification of tumors of T-cell origin; Catalog No. NCL-L-CD7-580; packaged in 1 mL vials and 0.1 mL vials; NCL-L-CD7-580 is intended for the qualitative identification by light microscopy of CD7 molecules in paraffin-embedded tissue by immunohistochemical staining. 1 mL vial, Product Code CD7-580-L-CE, 0.1 mL vial, Product Code CD7-580-L-CE-S. Recall # Z-1054-2012
CODE
1) Lot numbers: 08173, 11855 and 14784;
2) Lot numbers: 10604 and 13566;
3) Lot numbers: L158018,vL158019, L158020 and L158021
RECALLING FIRM/MANUFACTURER
Recalling Firm: Leica Microsystems, Inc., Buffalo Grove, IL, by letter dated January 4, 2012.
Manufacturer: Leica Biosystems Newcastle Ltd., Newcastle Upon Tyne, UK. Firm initiated recall is ongoing.
REASON
The primary antibodies to CD2 (clone 11F11) and CD7 (clone LP15) have been adulterated.
VOLUME OF PRODUCT IN COMMERCE
324 vials
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
Ascension Orthopedics First Choice Partial Ulnar Head System ("DRUJ System"). Head sizes 14.5 mm, 16.0 mm, 17.5 mm, and 19.0 mm each with stem sizes 4.5 mm, 5.5 mm, or 6.5 mm. The First Choice DRUJ System is intended for replacement of the distal radio-ulnar joint. The Partial Head implant is indicated for replacement of the distal ulnar head for rheumatoid, degenerative, or post-traumatic arthritis. This recall applies to all of the First Choice DRUJ Partial Ulnar Head Devices. of the following Catalog Numbers are included: DRUJ-610-1445-WW, DRUJ-610-1455-WW, DRUJ-610-1465-WW, DRUJ-610-1645-WW, DRUJ-610-1655-WW, DRUJ-610-1665-WW, DRUJ-610-1745-WW, DRUJ-610-1755-WW, DRUJ-610-1765-WW, DRUJ-610-1945-WW, DRUJ-610-1955-WW, and DRUJ-610-1965-WW. Recall # Z-1060-2012
CODE
All lot numbers
RECALLING FIRM/MANUFACTURER
Ascension Orthopedics, Inc., Austin, TX, by letter dated December 3, 2011. Firm initiated recall is ongoing.
REASON
Certain modifications were made to the First Choice System and should have been preceded by a submission of a filing with the FDA.
VOLUME OF PRODUCT IN COMMERCE
1,303 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
1)Strep A Rapid Test Cassette (K031784), IST-502 Cassettes. Brand Name (Catalog Number): Acceava Strep A Cassette (92004 E-Z); Accutest Integrated Strep A Rapid Test Device JANT (ID440); ACON Strep A Rapid Test Device (IST-502); BD Directigen EZ Group A Strep, Becton Dickinson (256032); Clearview Strep A Exact II Cassette (920003), CONSULT Diagnostics Strep A Cassette, 25T, PSS (5004); CONSULT Diagnostics Strep A Cassette, 50T, PSS (5009); Detector Strep A Direct, Immunostics (IMMIL-Strep25); E-Z Well Strep A Test Device, 25T, StanBio (6100-025L), E-Z Well Strep A Test Device, 5T, StanBio (6100-05L); Henry Schein One Step + Strep A Cassette Test (9004051); Medi-Lab Performance Strep A Test-Cassette, McKesson (32-502); Poly stat Strep A Cassette Test, Polymedco (STC 20); Signify Strep A Cassette (1P47-40); and SP Brand Strep A Rapid Cassette Test, Cardinal Health (B1077-26). Type of Packaging (ie. box, plastic bag): Individually pouched devices (number of tests per kit varies from 5 to 50), the kits also include: disposable extraction test tubes, dropper tips, sterile swabs, 1 vial Strep A reagent A (10 mL): 2M Sodium Nitrite, 1 vial Strep A reagent B (10 mL): 0.4M Acetic Acid, 1 vial Strep A positive control (1 mL): Nonviable Strep A; 0.09% NaN3, 1 vial Strep A negative control (1 mL): Nonviable Strep C; 0.09% NaN3 in a labeled kit box. The Strep A Rapid Test Cassette and Twist devices are qualitative, lateral flow immunoassays for the detection of Strep A carbohydrate antigen in a throat swab, providing results within 5 minutes. The tests utilize antibodies specific for whole cell Lancefield Group A Streptococcus to selectively detect Strep A antigen in a throat swab specimen. The Cassette device uses a drop-wise application method while the Twist device has an onboard well to extract the throat swab specimen. The Strep A Rapid Test Devices are rapid chromatographic immunoassays for the qualitative detection of Strep A antigen from throat swab specimens to aid in the diagnosis of Group A Streptococcal infection. This test is indicated for professional and point of care use only. Recall # Z-1074-2012;
2) Strep A Twist Rapid Test Cassette (K023766), IST-502T Twist Cassettes. Brand Name (Catalog Number): ACON Rapid Device Strep A Twist (IST-502T); CONSULT Diagnostics Strep A Twist, PSS (5005); Medi-Lab Performance Strep A Test-Twist, McKesson (32-502T); MooreBrand Strep A Twist Cassette, Moore (82793); and SP Strep A Rapid Twist Cassette Test, Cardinal Health (B1077-29). Type of Packaging (ie. box, plastic bag): Individually pouched devices (number of tests per kit varies from 5 to 50), the kits also include: disposable extraction test tubes, dropper tips, sterile swabs, 1 vial Strep A reagent A (10 mL): 2M Sodium Nitrite, 1 vial Strep A reagent B (10 mL): 0.4M Acetic Acid, 1 vial Strep A positive control (1 mL): Nonviable Strep A; 0.09% NaN3, 1 vial Strep A negative control (1 mL): Nonviable Strep C; 0.09% NaN3 in a labeled kit box. The Strep A Rapid Test Cassette and Twist devices are qualitative, lateral flow immunoassays for the detection of Strep A carbohydrate antigen in a throat swab, providing results within 5 minutes. The tests utilize antibodies specific for whole cell Lancefield Group A Streptococcus to selectively detect Strep A antigen in a throat swab specimen. The Cassette device uses a drop-wise application method while the Twist device has an onboard well to extract the throat swab specimen. The Strep A Rapid Test Devices are rapid chromatographic immunoassays for the qualitative detection of Strep A antigen from throat swab specimens to aid in the diagnosis of Group A Streptococcal infection. This test is indicated for professional and point of care use only. Recall # Z-1075-2012
CODE
All lots manufactured since August 2009.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Alere San Diego, San Diego, CA, by letter dated September 1, 2011.
Manufacturer: Abon Biopharm (Hangzhou) Co., Ltd. Hangzhou, Zhejiang, China. Firm Initiated recall is ongoing.
REASON
False positive test results.
VOLUME OF PRODUCT IN COMMERCE
4,657,030 devices (456 lots)
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
LH Lithium Heparin tubes, Greiner bio-one. Venous blood collection tubes.
a) Item #456087, b) Item #454244, c) Item #456087CA, d) Item #456287, e) Item #454237, and f) Item #456287. Recall # Z-1081-2012
CODE
a) Lot #B07115 and B08116, b) Lot #B091112, c) Lot #B091106, d) Lot #B101114, e) Lot #B091108 and f) Lot #B091110
RECALLING FIRM/MANUFACTURER
Greiner Bio-One North America, Inc., Monroe, NC, by letter dated December 13, 2011. Firm initiated recall is ongoing.
REASON
The lithium heparin tubes may have a contamination with EDTA potassium.
VOLUME OF PRODUCT IN COMMERCE
2,082,000 pieces
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Varian brand Varian 52-leaf Standard MLC multileaf collimator; Reference/FSCA Identifier: CP-04792; Model Number(s): All models, including H52, H54, H56, HHM; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA. The Multileaf Collimator is intended to assist the Radiation Oncologist in the delivery of radiation to well defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation. Recall # Z-1090-2012;
2) Varian brand 52-leaf Millennium MLC multileaf collimator; Reference/FSCA Identifier: CP-04792; All models, including H52, H54, H56, HHM. The Multileaf Collimator is intended to assist the Radiation Oncologist in the delivery of radiation to well defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation. Recall # Z-1091-2012
CODE
1) Serial Numbers/CODES: H520102 H520235 H520362 H520458 H520542 H520614 H520682 H520740 H520797 H520116 H520237 H520364 H520461 H520545 H520615 H520684 H520743 H520798 H520122 H520244 H520367 H520468 H520546 H520618 H520685 H520745 H520799 H520126 H520247 H520368 H520474 H520547 H520619 H520687 H520746 H520800 H520130 H520251 H520369 H520481 H520548 H520620 H520689 H520747 H520801 H520134 H520300 H520370 H520482 H520552 H520622 H520690 H520748 H520804 H520136 H520302 H520373 H520485 H520553 H520624 H520691 H520750 H520808 H520138 H520304 H520378 H520488 H520554 H520625 H520693 H520752 H520809 H520141 H520305 H520380 H520489 H520555 H520626 H520695 H520755 H520810 H520146 H520311 H520381 H520490 H520557 H520627 H520697 H520756 H520811 H520154 H520312 H520386 H520493 H520559 H520628 H520698 H520757 H520813 H520156 H520315 H520387 H520496 H520560 H520630 H520699 H520760 H520815 H520161 H520318 H520391 H520499 H520563 H520631 H520700 H520761 H520817 H520168 H520319 H520394 H520501 H520564 H520632 H520701 H520762 H520818 H520169 H520320 H520395 H520505 H520566 H520633 H520704 H520763 H520820 H520172 H520322 H520396 H520506 H520571 H520637 H520707 H520765 H520821 H520175 H520324 H520398 H520508 H520575 H520639 H520708 H520766 H520823 H520179 H520326 H520406 H520509 H520577 H520640 H520710 H520767 H520824 H520180 H520328 H520408 H520511 H520578 H520642 H520714 H520768 H520827 H520182 H520329 H520409 H520512 H520580 H520643 H520715 H520769 H520828 H520183 H520330 H520410 H520513 H520582 H520647 H520717 H520771 H520832 H520184 H520333 H520412 H520514 H520584 H520648 H520718 H520772 H520833 H520186 H520334 H520413 H520517 H520585 H520649 H520719 H520773 H520840 H520190 H520335 H520414 H520518 H520587 H520650 H520720 H520774 H520841 H520191 H520336 H520421 H520520 H520589 H520654 H520721 H520775 H520843 H520192 H520338 H520423 H520521 H520590 H520659 H520722 H520776 H520849 H520197 H520340 H520432 H520522 H520596 H520660 H520724 H520778 H520851 H520198 H520346 H520436 H520524 H520598 H520661 H520726 H520783 H520852 H520199 H520347 H520437 H520525 H520599 H520663 H520727 H520784 H520853 H520202 H520350 H520438 H520529 H520600 H520664 H520728 H520785 H520854 H520204 H520351 H520439 H520531 H520601 H520665 H520731 H520786 H520855 H520205 H520352 H520440 H520532 H520605 H520666 H520732 H520790 H520856 H520211 H520354 H520442 H520533 H520609 H520671 H520734 H520793 H520857 H520216 H520356 H520443 H520535 H520610 H520674 H520737 H520794 H520858 H520217 H520357 H520445 H520537 H520611 H520678 H520738 H520795 H520859 H520221 H520359 H520447 H520541 H520612 H520679 H520739 H520796 H520860 H541142 H561022 H561064 H561137 H561176 HHM0006 HHM0064 H541227 H561023 H561067 H561138 H561178 HHM0007 HHM0066 H541249 H561024 H561069 H561139 H561179 HHM0008 HHM0067 H541331 H561025 H561070 H561140 H561180 HHM0009 HHM0069 H541344 H561026 H561076 H561141 H561181 HHM0010 HHM0099 H541425 H561027 H561096 H561142 H561182 HHM0011 HHM1202 H541429 H561028 H561100 H561144 H561185 HHM0012 H541449 H561029 H561101 H561145 H561186 HHM0013 H541463 H561030 H561102 H561146 H561187 HHM0014 H541465 H561031 H561103 H561147 H561188 HHM0015 H541467 H561033 H561104 H561148 H561189 HHM0016 H541640 H561034 H561105 H561149 H561190 HHM0017 H542515 H561035 H561106 H561150 H561191 HHM0018 H542737 H561036 H561107 H561151 H561192 HHM0019 H542755 H561037 H561109 H561152 H561193 HHM0020 H542834 H561038 H561110 H561153 H561194 HHM0022 H543057 H561039 H561111 H561154 H561195 HHM0023 H543093 H561040 H561112 H561155 H561196 HHM0024 H543311 H561041 H561113 H561156 H561199 HHM0025 H544189 H561043 H561114 H561157 H561200 HHM0026 H545563 H561044 H561115 H561158 H561201 HHM0027 H545773 H561045 H561116 H561159 H561203 HHM0028 H561006 H561046 H561117 H561160 H561204 HHM0029 H561008 H561047 H561118 H561161 H561205 HHM0030 H561009 H561048 H561119 H561162 H561206 HHM0031 H561010 H561050 H561120 H561163 H561207 HHM0032 H561011 H561052 H561121 H561166 H561208 HHM0033 H561012 H561053 H561122 H561167 H561209 HHM0034 H561013 H561054 H561123 H561168 H561210 HHM0035 H561015 H561057 H561124 H561169 H561211 HHM0036 H561016 H561058 H561126 H561170 H561212 HHM0038 H561017 H561059 H561128 H561171 H561215 HHM0039 H561018 H561060 H561130 H561172 H563989 HHM0060 H561019 H561061 H561134 H561173 H564795 HHM0061 H561020 H561062 H561135 H561174 HHM0004 HHM0062 H561021 H561063 H561136 H561175 HHM0005 HHM0063;
2) Serial Numbers/CODES: H520102 H520235 H520362 H520458 H520542 H520614 H520682 H520740 H520797 H520116 H520237 H520364 H520461 H520545 H520615 H520684 H520743 H520798 H520122 H520244 H520367 H520468 H520546 H520618 H520685 H520745 H520799 H520126 H520247 H520368 H520474 H520547 H520619 H520687 H520746 H520800 H520130 H520251 H520369 H520481 H520548 H520620 H520689 H520747 H520801 H520134 H520300 H520370 H520482 H520552 H520622 H520690 H520748 H520804 H520136 H520302 H520373 H520485 H520553 H520624 H520691 H520750 H520808 H520138 H520304 H520378 H520488 H520554 H520625 H520693 H520752 H520809 H520141 H520305 H520380 H520489 H520555 H520626 H520695 H520755 H520810 H520146 H520311 H520381 H520490 H520557 H520627 H520697 H520756 H520811 H520154 H520312 H520386 H520493 H520559 H520628 H520698 H520757 H520813 H520156 H520315 H520387 H520496 H520560 H520630 H520699 H520760 H520815 H520161 H520318 H520391 H520499 H520563 H520631 H520700 H520761 H520817 H520168 H520319 H520394 H520501 H520564 H520632 H520701 H520762 H520818 H520169 H520320 H520395 H520505 H520566 H520633 H520704 H520763 H520820 H520172 H520322 H520396 H520506 H520571 H520637 H520707 H520765 H520821 H520175 H520324 H520398 H520508 H520575 H520639 H520708 H520766 H520823 H520179 H520326 H520406 H520509 H520577 H520640 H520710 H520767 H520824 H520180 H520328 H520408 H520511 H520578 H520642 H520714 H520768 H520827 H520182 H520329 H520409 H520512 H520580 H520643 H520715 H520769 H520828 H520183 H520330 H520410 H520513 H520582 H520647 H520717 H520771 H520832 H520184 H520333 H520412 H520514 H520584 H520648 H520718 H520772 H520833 H520186 H520334 H520413 H520517 H520585 H520649 H520719 H520773 H520840 H520190 H520335 H520414 H520518 H520587 H520650 H520720 H520774 H520841 H520191 H520336 H520421 H520520 H520589 H520654 H520721 H520775 H520843 H520192 H520338 H520423 H520521 H520590 H520659 H520722 H520776 H520849 H520197 H520340 H520432 H520522 H520596 H520660 H520724 H520778 H520851 H520198 H520346 H520436 H520524 H520598 H520661 H520726 H520783 H520852 H520199 H520347 H520437 H520525 H520599 H520663 H520727 H520784 H520853 H520202 H520350 H520438 H520529 H520600 H520664 H520728 H520785 H520854 H520204 H520351 H520439 H520531 H520601 H520665 H520731 H520786 H520855 H520205 H520352 H520440 H520532 H520605 H520666 H520732 H520790 H520856 H520211 H520354 H520442 H520533 H520609 H520671 H520734 H520793 H520857 H520216 H520356 H520443 H520535 H520610 H520674 H520737 H520794 H520858 H520217 H520357 H520445 H520537 H520611 H520678 H520738 H520795 H520859 H520221 H520359 H520447 H520541 H520612 H520679 H520739 H520796 H520860 H541142 H561022 H561064 H561137 H561176 HHM0006 HHM0064 H541227 H561023 H561067 H561138 H561178 HHM0007 HHM0066 H541249 H561024 H561069 H561139 H561179 HHM0008 HHM0067 H541331 H561025 H561070 H561140 H561180 HHM0009 HHM0069 H541344 H561026 H561076 H561141 H561181 HHM0010 HHM0099 H541425 H561027 H561096 H561142 H561182 HHM0011 HHM1202 H541429 H561028 H561100 H561144 H561185 HHM0012 H541449 H561029 H561101 H561145 H561186 HHM0013 H541463 H561030 H561102 H561146 H561187 HHM0014 H541465 H561031 H561103 H561147 H561188 HHM0015 H541467 H561033 H561104 H561148 H561189 HHM0016 H541640 H561034 H561105 H561149 H561190 HHM0017 H542515 H561035 H561106 H561150 H561191 HHM0018 H542737 H561036 H561107 H561151 H561192 HHM0019 H542755 H561037 H561109 H561152 H561193 HHM0020 H542834 H561038 H561110 H561153 H561194 HHM0022 H543057 H561039 H561111 H561154 H561195 HHM0023 H543093 H561040 H561112 H561155 H561196 HHM0024 H543311 H561041 H561113 H561156 H561199 HHM0025 H544189 H561043 H561114 H561157 H561200 HHM0026 H545563 H561044 H561115 H561158 H561201 HHM0027 H545773 H561045 H561116 H561159 H561203 HHM0028 H561006 H561046 H561117 H561160 H561204 HHM0029 H561008 H561047 H561118 H561161 H561205 HHM0030 H561009 H561048 H561119 H561162 H561206 HHM0031 H561010 H561050 H561120 H561163 H561207 HHM0032 H561011 H561052 H561121 H561166 H561208 HHM0033 H561012 H561053 H561122 H561167 H561209 HHM0034 H561013 H561054 H561123 H561168 H561210 HHM0035 H561015 H561057 H561124 H561169 H561211 HHM0036 H561016 H561058 H561126 H561170 H561212 HHM0038 H561017 H561059 H561128 H561171 H561215 HHM0039 H561018 H561060 H561130 H561172 H563989 HHM0060 H561019 H561061 H561134 H561173 H564795 HHM0061 H561020 H561062 H561135 H561174 HHM0004 HHM0062 H561021 H561063 H561136 H561175 HHM0005 HHM0063
RECALLING FIRM/MANUFACTURER
Varian Medical Systems, Inc. Oncology Systems, Palo Alto, CA, letter dated January 16, 2012. Firm initiated recall is ongoing.
REASON
When using the Standard and Millennium 52-leaf MLC multi-leaf collimators for beam shaping, under specific treatment conditions, dose may be delivered outside of the intended treatment field that exceed the expected transmission dose.
VOLUME OF PRODUCT IN COMMERCE
618 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
CyberKnife Robotic Radiosurgery System with 4D Planning procedure option of MultiPlan Treatment Planning System, versions 3.0, 3.1, 3.5.1, 3.5.2 and 3.5.3 with Ray-Tracing dose calculation. Treatment planning and image guided stereotactic radiosurgery and precision radiotherapy of lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. Model number: P/N 025153. Recall # Z-1098-2012
CODE
Versions 3.0, 3.1, 3.5.1, 3.5.2 and 3.5.3
RECALLING FIRM/MANUFACTURER
Accuray Inc., Sunnyvale, CA, by letter dated January 16, 2012. Firm initiated recall is ongoing.
REASON
An anomaly was discovered during internal regression testing, where the dose information is displayed incorrectly during treatment planning during a specific workflow using the optional 4D Ray Tracing dose calculation algorithm. As a result, it is possible that the dose calculation will display a lower dose than the intended dose prescribed for treatment delivery.
VOLUME OF PRODUCT IN COMMERCE
207 units
DISTRIBUTION
Nationwide and Internationally
RECALLS AND FIELD CORRECTIONS: DEVICES – CLASS III
___________________________________
PRODUCT
Provent -SR - Sleep Apnea Therapy-SR (standard resistance). Prescription only, Single Use; Packed 30 units per box. Catalog number MRS0227; Used in the treatment of obstructive sleep apnea. Recall # Z-1033-2012
CODE
Lot number: 14261182
RECALLING FIRM/MANUFACTURER
Ventus Medical, Inc., Belmont, CA, by letter dated February 3, 2012. Firm initiated recall is complete.
REASON
A discrepancy was found during inspection of a returned unit that the lot number and SKU on cartoon did not match.
VOLUME OF PRODUCT IN COMMERCE
288 units
DISTRIBUTION
Nationwide
RECALLS AND FIELD CORRECTIONS: VETERINARY – CLASS I
___________________________________
PRODUCT
1) DOG POWER(R) BRAND DOG FOOD, ADULT MAINTENANCE FORMULA 21-12. Net Wt. 50 lb (22.67) kg, UPC 722304276942. Recall # V-041-2012;
2) DOG POWER(R) BRAND DOG FOOD, HI-PRO PERFORMANCE FORMULA 26-18. Net Wt. 50 lb (22.67) kg, UPC 722304276959. Recall # V-042-2012;
3) DOG POWER(R) BRAND DOG FOOD, HUNTERS FORMULA 27-14, Net Wt. 50 lb (22.67) kg, UPC 722304276966. Recall # V-043-2012
CODE
1) Lot numbers 4K1004 thru 4K1322;
2) Lot numbers 4K1010 thru 4K1161;
3) Lot numbers 4K1008 thru 4K1159
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hirsch Feed & Farm Supply Inc., Thayer, MO, by telephone on December 6, 2011, letters and emails on December 8, 2011 and press release on December 9, 2011 and December 14, 2011.
Manufacturer: Cargill Inc Animal Nutrition Division, Lecompte, LA. Firm initiated recall is ongoing.
REASON
Dog food was manufactured with corn that had higher than acceptable Aflatoxin levels.
VOLUME OF PRODUCT IN COMMERCE
29,357 bags
DISTRIBUTION
AR, MO
___________________________________
PRODUCT
1) ARROWBRAND 21% Dog Chunks, #807, Net Weight 18.18 kg (40 lb). Recall # V-044-2012;
2) ARROWBRAND Super Proeaux Dog Food, #812, Net Weight 18.18 kg (40 lb). Recall # V-045-2012;
3) ARROWBRAND Professional Formula Dog Food, #814, Net Weight 22.68 kg (50 lb). Recall # V-046-2012
CODE
1), 2), and 3) Units: 4K0341 - 4K0365 and 4K1001 - 4K1325
RECALLING FIRM/MANUFACTURER
Recalling Firm: O'Neal's Feeders Supply, Inc., DeRidder, LA, by telephone and letters on December 8, 2011 and by press release on December 10, 2011 and December 14, 2011.
Manufacturer: Cargill Inc Animal Nutrition Division, Lecompte, LA. Firm initiated recall is ongoing.
REASON
Dog food was manufactured with corn which had higher than acceptable levels of aflatoxin.
VOLUME OF PRODUCT IN COMMERCE
16,461 units
DISTRIBUTION
LA and East TX
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PRODUCT
PETRUS FEEDS, 21% Dog Food, Net Wt 40 lbs. (18.14 kg). Recall # V-047-2012
CODE
Lot numbers LL1001 through LL1335
RECALLING FIRM/MANUFACTURER
Recalling Firm: Petrus Feed & Seed Stores Inc., Alexandria, LA, by a Press Release on December 13, 2011 and a corrected one was issued on December 14, 2012.
Manufacturer: Cargill Inc Animal Nutrition Division, Lecompte, LA. Firm initiated recall is ongoing.
REASON
Dog food was manufactured with corn which had higher than acceptable levels of aflatoxin.
VOLUME OF PRODUCT IN COMMERCE
2,489 bags
DISTRIBUTION
LA
END OF ENFORCEMENT REPORT FOR FEBRUARY 29, 2012.
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