Drugs
Warning Letters 2009
2009 Warning Letters and Untitled Letters to Pharmaceutical Companies
These letters, sorted by month, are supplied by the CDER Freedom of Electronic Information Office. This page only covers Division of Drug Marketing and Communications and Headquarters Warning Letters. For District Office Warning Letters see the Main FDA FOI Warning Letters Page. Some of the letters have been redacted or edited to remove confidential information. Click on the links in each month to view the letters in Adobe Acrobat format. [more...]
December 2009
| Product/Issue | Company/Individual | Division | Released | Posted |
|---|---|---|---|---|
NDA 21-225 | Bayer HealthCare Pharmaceuticals Inc. | Division of Drug Marketing, Advertising, and Communications | 12/30/09 | 1/12/10 |
NDA 21-773, 21-919 | Amylin Pharmaceuticals, Inc. | Division of Drug Marketing, Advertising, and Communications | 12/24/09 | 1/12/10 |
NDA # 22-249, NDA # 22-303 Treanda® (bendamustine hydrochloride) for Injection | Cephalon, Inc. | Division of Drug Marketing, Advertising, and Communications | 12/18/09 | 1/12/10 |
Clinical Investigator | John A. Ward, M.D. | Division of Scientific Investigations | 12/3/09 | 12/22/09 |
November 2009
| Product/Issue | Company/Individual | Division | Released | Posted |
|---|---|---|---|---|
Sponsor-Applicant-Monitor-Clinical Research Organization | ICON Clinical Research | Division of Scientific Investigations | 11/27/09 | 12/8/09 |
Clinical Investigator | Craig M. Buettner, M.D. | Division of Scientific Investigations | 11/24/09 | 12/15/09 |
Clinical Investigator | Thomas Gazda, M.D. | Division of Scientific Investigations | 11/24/09 | 1/12/10 |
NDA 18-332 | Iroko Pharmaceuticals, LLC | Division of Drug Marketing, Advertising, and Communications | 11/17/09 | 11/20/09 |
Internet Marketing of Unapproved and Misbranded Drugs | Chen-Yu Ou (366rx.com, rxabode.com, and rxcart.com) | Office of Compliance | 11/16/09 | 11/19/09 |
Internet Marketing of Unapproved and Misbranded Drugs | I-warez Randek (thewomantour.com) | Office of Compliance | 11/16/09 | 11/19/09 |
Internet Marketing of Unapproved and Misbranded Drugs | Dr. Antonio Mendez (uk-online-pharmacy.com and online-pharmacy-4u.com) | Office of Compliance | 11/16/09 | 11/19/09 |
Internet Marketing of Unapproved and Misbranded Drugs | Forrest Media Incorporated (approved-swiss-meds.com, buy-rx-today.com, direct-rx-refill.com, value-european-pharmacy.com, mypillsfinder.com, dutyfreemeds.com, swissmeds.com, bestrxdeal.com, happypharmacy.net and european-pharm.com) | Office of Compliance | 11/16/09 | 11/19/09 |
Internet Marketing of Unapproved and Misbranded Drugs | Orion Star & Associates, Inc. (i-want-rx.com, refill-online.com, ultra-rx.com, trust-pharm.com, trust-european-pharmacy.com, pill-planet.com, and pharmacy-usa.biz) | Office of Compliance | 11/16/09 | 11/19/09 |
Internet Marketing of Unapproved and Misbranded Drugs | Lorna Hillier (buyonlinemedications.com) | Office of Compliance | 11/16/09 | 11/19/09 |
Internet Marketing of Unapproved and Misbranded Drugs | Pro West Marketing Ltd (doctorphentermine.com, trusted-tabs.us, online-pharmacy-no-prescription.com, 365pharm.com, approved-pharm.com, value-drugstore.com, cheapphentermine.com, rx-giant.com, 4cheaprx.com, preferredpharma.com, prescriptionsintl.com, aprixe.com, buycanadianpharmacy.net, terameds.org, dragon-rx.com, first-refill-c1ub.com, bestrxpharm.net, pharma-direct.com, buy-canadian-pharm.com, easy-pharm.com, licensed-medical.com, my-refilldrugstore. com, refill-rx-now.com, rxcalm.com, top-hotpills.com, top-uspharm.com, my-pill.com, smsrx.net, total-pharma.com, pharma-discounts.com, and rxontv.com) | Office of Compliance | 11/16/09 | 11/19/09 |
Internet Marketing of Unapproved and Misbranded Drugs | Buzz net - BUZZ LLC (cheap-phentermine-online.net) | Office of Compliance | 11/16/09 | 11/19/09 |
Internet Marketing of Unapproved and Misbranded Drugs | Andrey Petroff (shrinkrapthemovie.com, bikekmba.org, dinnerdvrsLcom, myfleacircus.com, petpetcentral.com, sorasheart.com, and walona.com) | Office of Compliance | 11/16/09 | 11/19/09 |
Internet Marketing of Unapproved and Misbranded Drugs | Sinan Akyuz (onlinepharmacynorx.info) | Office of Compliance | 11/16/09 | 11/19/09 |
Internet Marketing of Unapproved and Misbranded Drugs | Michael Trinidad - tvforever (michaelpharmacy.com, mywebmarquee.com, pharmazero.com, and pharmalove.com) | Office of Compliance | 11/16/09 | 11/19/09 |
Internet Marketing of Unapproved and Misbranded Drugs | D Hunter (medspricedright.com and valuedrugspharmacy.com) | Office of Compliance | 11/16/09 | 11/19/09 |
Internet Marketing of Unapproved and Misbranded Drugs | Sinan Akyuz (goask.org) | Office of Compliance | 11/16/09 | 11/19/09 |
Internet Marketing of Unapproved and Misbranded Drugs | Chris Walsh c/o Dynadot Privacy
| Office of Compliance | 11/16/09 | 11/19/09 |
Internet Marketing of Unapproved and Misbranded Drugs | Xanos Holdings Inc. (direct-pharm.com, us-value-pharm.com, global-drugstore.com, refill-club.com, global-generics-source.com, european-drugstore.com, first-canadian-pharm.com, mexican-pharm.com, pillsshipping.com, rxgenericsstore.com, americanmedsdirect.com, and usrxmeds.net) | Office of Compliance | 11/16/09 | 11/19/09 |
Internet Marketing of Unapproved and Misbranded Drugs | Krest Holdings (approved-swiss-drugstore.com, swiss-meds.com, approved-refill-club.com, first-refill-online.com, rxpharm.ws, global-rx-pharm.com, refill-drugstore.com, generics-pharm.net, mediwax.com, discountwebmeds.com, approved-medical.com, allgenericpills.com, rxbynet.com, and pricedpills.com) | Office of Compliance | 11/16/09 | 11/19/09 |
Internet Marketing of Unapproved and Misbranded Drugs | onlinepharmacyy.com | Office of Compliance | 11/16/09 | 11/19/09 |
Internet Marketing of Unapproved and Misbranded Drugs | Med Light LTD (refill-rxmeds.com, brand-meds.com, buy-american-pharma.com, online-pharma-rx.com, rx-easypharmacy.com, first-american-pharmacy.com, brand-pharma.com, secure-rx-refills.com, american-pharm.com, first-swiss-meds.com, rx-life.com, quickgeneric.com, us-pharmacy.us, epharmacy-usa.com, and medscourier.com) | Office of Compliance | 11/16/09 | 11/19/09 |
Internet Marketing of Unapproved and Misbranded Drugs | Ric Deleon (247meds.com, 24-7pills.com, 24-7rx.com, and bestdealrx.com) | Office of Compliance | 11/16/09 | 11/19/09 |
Internet Marketing of Unapproved and Misbranded Drugs | New Horizons LTD (topdrugstore.net, us-rx-meds.com, first-swiss-pharm.com, first-swiss-pharmacy.com, mexicanpharma.com, central-rx-refill.com, cheapdrugsmd.com, pharmacytouch.com, lion-rx.com, mypillshop.net, american-pharma.com, approved-swiss-pharm.com, approved-swisspharma.com, approved-swiss-pharmacy.com, and first-swiss-drugstore.com) | Office of Compliance | 11/16/09 | 11/19/09 |
Internet Marketing of Unapproved and Misbranded Drugs | William Wynne (andersenpharmacy.com and dukepharmacy.com?) | Office of Compliance | 11/16/09 | 11/19/09 |
Internet Marketing of Unapproved and Misbranded Drugs | Eugene Lefter (wellknowndrugs.com) | Office of Compliance | 11/16/09 | 11/19/09 |
Clinical Investigator | Anthony Dallas, M.D. | Division of Scientific Investigations | 11/9/09 | 11/17/09 |
Dacogen® (decitabine) | Eisai, Inc. | Division of Drug Marketing, Advertising, and Communications | 11/6/09 | 11/13/09 |
Fosrenol® (lanthanum carbonate hydrate) Chewable Tablets | Shire Development Inc | Division of Drug Marketing, Advertising, and Communications | 11/5/09 | 11/13/09 |
H1N1 Flu Virus-Related Products | Silver Soft for Skin | Office of Compliance | 11/4/09 | 4/23/10 |
October 2009
| Product/Issue | Company/Individual | Division | Released | Posted |
|---|---|---|---|---|
VICKS DayQuil Plus Vitamin C and VICKS NyQuil Plus Vitamin C | Procter and Gamble | Office of Compliance | 10/29/09 | 10/30/09 |
NDA # 21-287 | Sanofi-Aventis U.S. LLC | Division of Drug Marketing, Advertising, and Communications | 10/23/09 | 10/27/09 |
Clinical Investigator | Charles McKay, MD | Division of Scientific Investigations | 10/23/09 | 11/13/09 |
Institutional Review Board | MI Hope Inc. dba Center for Complex Infectious Diseases | Division of Scientific Investigations | 10/19/09 | 12/29/09 |
| King Pharmaceuticals, Inc. | Division of Drug Marketing, Advertising, and Communications | 10/8/09 | 10/22/09 |
Codeine Sulfate Tablets, 30 mg & 60 mg | Cerovene, Inc. | Division of New Drugs and Labeling Compliance | 10/13/09 | 10/13/09 |
Codeine Sulfate Tablets, 30 mg | Dava International, Inc. | Division of New Drugs and Labeling Compliance | 10/13/09 | 10/13/09 |
Codeine Sulfate Tablets, 30 mg & 60 mg | Glenmark Generics, Inc. | Division of New Drugs and Labeling Compliance | 10/13/09 | 10/13/09 |
Codeine Sulfate Tablets, 30 mg & 60 mg | Lehigh Valley Technologies, Inc. | Division of New Drugs and Labeling Compliance | 10/13/09 | 10/13/09 |
Institutional Review Board | Burzynski Research Institute IRB | Division of Scientific Investigations | 10/5/09 | 12/8/09 |
September 2009
| Product/Issue | Company/Individual | Division | Released | Posted |
|---|---|---|---|---|
Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus | SKW Ventures | Office of Compliance | 9/14/09 | 10/22/09 |
Viraban Hand Sanitizers; Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus | Kevin Lilly
| Office of Compliance | 9/14/09 | 10/22/09 |
ANDA #40-541 Sotradecol™ (sodium tetradecyl sulfate injection) | Bioniche Pharma | Division of Drug Marketing, Advertising, and Communications | 9/14/09 | 9/16/09 |
NDA #22-369 LatisseTM (bimatoprost ophthalmic solution) 0.03% | Allergan, Inc. | Division of Drug Marketing, Advertising, and Communications | 9/10/09 | 9/16/09 |
August 2009
| Product/Issue | Company/Individual | Division | Released | Posted |
|---|---|---|---|---|
Sodium Tetradecyl Sulfate (STS) Injection, 2%, 4% and 5% | Hopewell Pharmacy and Compounding Center aka Drugs Are Us, Inc | Division of New Drugs and Labeling Compliance | 8/28/09 | 11/13/09 |
API Manufacturing
| Sumitomo Chemical Company Limited | Division of Manufacturing and Product Quality | 8/24/09 | 10/13/09 |
ERTACZO™ (sertaconazole nitrate) Cream, 2% (Warning Letter) | Johnson & Johnson, Consumer & Personal Products Worldwide | Division of Drug Marketing, Advertising, and Communications | 8/21/09 | 8/25/09 |
Nalfon® (fenoprofen calcium capsules) 200 mg and 400 mg (Warning Letter) | Pedinol Pharmacal, Inc. | Division of Drug Marketing, Advertising, and Communications | 8/20/09
| 8/25/09 |
Tri-Luma® Cream (fluocinolone acetonide 0.01%, hydroquinone 4%, tretinoin 0.05%) (Warning Letter) | Galderma Laboratories | Division of Drug Marketing, Advertising, and Communications | 8/18/09 | 8/21/09 |
Tri-Luma Cream (fluocinolone acetonide 0.01 %; hydroquinone 4%; tretinoin 0.05%), NDA 21-112 (Warning Letter) | Hill Dermaceuticals, Inc. | Division of New Drugs and Labeling Compliance | 8/18/09 | 9/16/09 |
(Warning Letter) | Allergan, Inc. | Division of Drug Marketing, Advertising, and Communications | 8/17/09 | 8/21/09 |
(Warning Letter) | Cambrex Profarmaco Milano | Division of Manufacturing and Product Quality | 8/12/09 | 9/16/09 |
Sponsor-Applicant-Monitor-Clinical Research Organization (Warning Letter)
| Karen Grosser, Ph.D, MBA, Johnson & Johnson Pharmaceutical Research & Development IRB | Division of Scientific Investigations | 8/10/09 | 8/21/09 |
Manufacture of non-sterile APIs (Warning Letter) | Bayer HealthCare | Division of Manufacturing and Product Quality | 8/5/09 | 9/16/09 |
July 2009
| Product/Issue | Company/Individual | Division | Released | Posted |
|---|---|---|---|---|
Institutional Review Board | CHRISTUS Schumpert Health System IRB | Division of Scientific Investigations | 7/30/09 | 8/21/09 |
(Warning Letter)
| Barbara A. Harris, Ph.D. | Division of Scientific Investigations | 7/27/09 | 8/21/09 |
(Warning Letter) | Antibioticos do Brasil Uda. | Division of Manufacturing and Product Quality | 7/24/09 | 8/21/09 |
H1N1 Flu Virus- Related Products | Tcmhelpme | Office of Compliance | 7/22/09 | 10/22/09 |
| Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus (Warning Letter) | Q-Based Solutions, Inc. | Office of Compliance | 7/22/09 | 7/27/09 |
All Soapopular hand sanitizers (Warning Letter)
| MGS Representations | Office of Compliance | 7/15/09 | 7/23/09 |
(Warning Letter)
| Abbott Laboratories | Division of Drug Marketing, Advertising, and Communications | 7/14/09 | 7/22/09 |
NDA #19-618 Rowasa® (mesalamine) Rectal Suspension Enema
| Alaven Pharmaceutical LLC | Division of Drug Marketing, Advertising, and Communications | 7/13/09 | 7/22/09 |
June 2009
| Product/Issue | Company/Individual | Division | Released | Posted |
|---|---|---|---|---|
Non-sterile oral solid dosage drug products(Warning Letter)
| Apotex, Inc. | Division of Manufacturing and Product Quality | 6/25/09 | 7/22/09 |
Human drug finished product | Laboratoire Atlas, Inc. | Division of Manufacturing and Product Quality | 6/25/09 | 7/22/09 |
Clinical Investigator | Mark Gordon, M.D. | Division of Scientific Investigations | 6/26/2009 | 7/7/09 |
Clinical Investigator | Dov Linzer, MD | Division of Scientific Investigations | 6/12/2009 | 6/12/2009 |
Clinical Investigator | Noli R Zosa, M.D. | Division of Scientific Investigations | 6/16/2009 | 7/7/09 |
| Millennium Pharmaceuticals, Inc. | Division of Drug Marketing, Advertising, and Communications | 6/18/2009 | 6/23/09 |
May 2009
| Product/Issue | Company/Individual | Division | Released | Posted |
|---|---|---|---|---|
Alinia (nitazoxanide) Tablets and (nitazoxanide) for Oral Suspension | Romark Laboratories, L.C. | Division of Drug Marketing, Advertising, and Communications | 5/26/2009 | 6/22/09 |
PerioChip (chlorhexidine gluconate) (Warning Letter) | Dexcel Pharma Technologies Ltd. | Division of Drug Marketing, Advertising, and Communications | 5/14/2009 | 5/19/2009 |
Spectracef (cefditoren pivoxil) Tablets (Warning Letter) | Cornerstone Therapeutics, Inc. | Division of Drug Marketing, Advertising, and Communications | 5/4/2009 | 5/19/2009 |
| ULTRAM ER (tramadol HCl) (Warning Letter) | Johnson & Johnson | Division of Drug Marketing, Advertising, and Communications | 5/12/2009 | 5/19/2009 |
| Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus | Amrita Aromatherapy, Inc | Office of Compliance | 5/28/2009 | 6/22/2009 |
| Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus | Nozin LLC | Office of Compliance | 5/22/2009 | 6/22/2009 |
April 2009
| Product/Issue | Company/Individual | Division | Released | Posted |
|---|---|---|---|---|
Clinical Investigator | Francisco Hernandez, MD | Division of Scientific Investigations | 4/20/2009 | 4/20/2009 |
| Taxotere (docetaxel) | sanofi-aventis | Division of Drug Marketing, Advertising, and Communications | 4/16/2009 | 5/13/2009 |
| Institutional Review Board (Warning Letter) | Coast IRB | Division of Scientific Investigations | 4/14/2009 | 4/14/2009 |
(Warning Letter) | Qingdao Jiulong Biopharmaceuticals Co. Ltd. | Division of Manufacturing and Product Quality | 4/14/2009 | 4/16/2009 |
Clinical Investigator | Bruce Branitz, MD | Division of Scientific Investigations | 4/9/2009 | 4/9/2009 |
BLA 125104 Tysabri (natalizumab) injection for intravenous use
| Biogen Idec | Division of Drug Marketing, Advertising, and Communications | 4/2/2009 | 4/3/2009 |
NDA 20-839 Plavix (clopidogrel bisulfate) Tablets | Sanofi Aventis, U.S. | Division of Drug Marketing, Advertising, and Communications | 4/2/2009 | 4/3/2009 |
NDA 21-400 LEVITRA (vardenafil HCl) Tablets; NDA 21-676, 21-873, 22-045 YAZ (drospirenone and ethinyl estradiol) Tablets; NDA 21-225 Mirena (levonorgestrel-releasing intrauterine system) | Bayer Healthcare Pharmaceuticals, Inc. | Division of Drug Marketing, Advertising, and Communications | 4/2/2009 | 4/3/2009 |
NDA 21-071 Avandia (rosiglitazone maleate) Tablets; NDA 21-410 Avandamet (rosiglitazone maleate and metformin hydrochloride) Tablets; NDA 21-700 Avandaryl (rosiglitazone maleate and glimepiride) Tablets; NDA 21-319 Avodart (dutasteride) Soft Gelatin Tablets; NDA 22-012 Coreg CR (carvedilol phosphate) Extended-release Capsules; NDA 22-059 Tykerb (lapatinib) Tablets | GlaxoSmithKline | Division of Drug Marketing, Advertising, and Communications | 4/2/2009 | 4/3/2009 |
NDA 21-742 BYSTOLIC (nebivolol) Tablets; NDA 21-431 CAMPRAL (acamprosate calcium) Delayed-Release Tablets; NDA 21-323, 21-365, 21-440 Lexapro (escitalopram) Tablets/ Oral Solution; NDA 21-487, 21-627 Namenda (memantine) Tablets/Oral Solution | Forest Laboratories, Inc. | Division of Drug Marketing, Advertising, and Communications | 4/2/2009 | 4/3/2009 |
NDA 21-947 FENTORA (fentanyl buccal tablet); NDA #22-249 TREANDA (bendamustine hydrochloride) for Injection, for intravenous infusion | Cephalon, Inc. | Division of Drug Marketing, Advertising, and Communications | 4/2/2009 | 4/3/2009 |
NDA 21-976 PREZISTA (darunavir) Tablet | Johnson & Johnson Pharmaceutical Services | Division of Drug Marketing, Advertising, and Communications | 4/2/2009 | 4/3/2009 |
NDA 20-753 AROMASIN (exemestane) tablets; NDA 21-540 CADUET (amlodipine besylate/atorvastatin calcium) Tablets; NDA 21-928 CHANTIX® (varenicline) Tablets; NDA 21-228 Detrol LA (tolterodine tartrate) extended release capsules; NDA 21-446, 21-723, 21-724 LYRICA (pregabalin) Capsules; NDA 20-998, 21-156 CELEBREX (celecoxib) capsules | Pfizer, Inc. | Division of Drug Marketing, Advertising, and Communications | 4/2/2009 | 4/3/2009 |
NDA 20-726 Femara (letrozole tablets); NDA 21-283 Diovan (valsartan) Tablets; NDA 21-990 Exforge (amlodipine and valsartan) Tablets; NDA 21-882 EXJADE (deferasirox) Tablets for Oral Suspension; NDA 21-588 GLEEVEC (imatinib mesylate) Tablets for Oral Use | Novartis Pharmaceuticals Corp. | Division of Drug Marketing, Advertising, and Communications | 4/2/2009 | 4/3/2009 |
BLA 125085 Avastin (Bevacizumab); BLA 125156 LUCENTIS (ranibizumab injection); BLA 103705, 103737 RITUXAN (rituximab); BLA 103976 Xolair (Omalizumab) For Subcutaneous Use; BLA 103792 HERCEPTIN (trastuzumab); BLA 103532 Pulmozyme (dornase alfa) Inhalation Solution | Genentech, Inc. | Division of Drug Marketing, Advertising, and Communications | 4/2/2009 | 4/3/2009 |
NDA 21-395 Spiriva HandiHaler (tiotropium bromide inhalation powder); NDA 20-579 Flomax (tamsulosin hydrochloride) Capsules; NDA 20-667 Mirapex (pramipexole dihydrochloride) Tablets | Boehringer Ingelheim Pharmaceuticals, Inc. | Division of Drug Marketing, Advertising, and Communications | 4/2/2009 | 4/3/2009 |
NDA 21-995 JANUVIA (sitagliptin) Tablets; NDA 20-788 PROPECIA (finasteride) Tablets; NDA 20-829, 20-830, 21-409 SINGULAIR (montelukast sodium) granule; | Merck & Co., Inc. | Division of Drug Marketing, Advertising, and Communications | 4/2/2009 | 4/3/2009 |
NDA 21-455, 21-858 BONIVA (ibandronate sodium) Tablets; BLA 103964 PEGASYS (peginterferon alfa-2a) for Injection; NDA 20-896 XELODA (capecitabine) Tablets | Hoffman-LaRoche, Inc. | Division of Drug Marketing, Advertising, and Communications | 4/2/2009 | 4/3/2009 |
NDA 21-427, 21-733, 22-148 Cymbalta (duloxetine hydrochloride) Delayed-
| Eli Lilly and Co. | Division of Drug Marketing, Advertising, and Communications | 4/2/2009 | 4/3/2009 |
March 2009
| Product/Issue | Company/Individual | Division | Released | Posted |
|---|---|---|---|---|
(Warning Letter) | Ronald Bukowski, M.D. | Division of Scientific Investigations | 3/30/2009 | 4/21/2009 |
Morphine Sulfate Tablets, 15 mg & 30 mg; Morphine Sulfate Solution Immediate Release Concentrate, 20 mg/ml; Morphine Sulfate Solution Immediate Release Oral Solution, 20mg/5ml | Glenmark Generics, Inc. | Office of Compliance | 3/30/2009 | 3/31/2009 |
Morphine Sulfate Solution Immediate Release Concentrate, 20 mg/ml; Hydromorphone HCI Tablets, 2mg and 4mg | Lannett Company, Inc. | Office of Compliance | 3/30/2009 | 3/31/2009 |
Morphine Sulfate Tablets, 15 mg & 30 mg; Morphine Sulfate Solution Concentrate, 20 mg/ml | Lehigh Valley Technologies, Inc. | Office of Compliance | 3/30/2009 | 3/31/2009 |
Morphine Sulfate Concentrate Oral Solution 20mg/ml | Mallinckrodt Inc. Pharmaceuticals Group | Office of Compliance | 3/30/2009 | 3/31/2009 |
Roxanol Oral Solution, 20 mg/ml; Roxicodone Tablets, 5 mg | Xanodyne Pharmaceuticals, Inc. | Office of Compliance | 3/30/2009 | 3/31/2009 |
Morphine Sulfate Immediate Release Tablets, 30 mg; Hydromorphone Tablets, 2 mg; | Physicians Total Care, Inc. | Office of Compliance | 3/30/2009 | 3/31/2009 |
Hydromorphone Hydrochloride Tablets, 2 mg & 4 mg | Roxane Laboratories, Inc. | Office of Compliance | 3/30/2009 | 3/31/2009 |
Roxanol Oral Solution, 20 mg/ml; Roxicodone Tablets, 5 mg | Boehringer Ingelheim Roxane, Inc. | Office of Compliance | 3/30/2009 | 3/31/2009 |
Morphine Sulfate Solution Immediate Release 20mg/ml | Cody Laboratories, Inc. | Office of Compliance | 3/30/2009 | 3/31/2009 |
Clinical Investigator | Daniel M. Paulson, MD | Division of Scientific Investigations | 3/11/2009 | 3/11/2009 |
Treximet (sumatriptan and naproxen sodium) Tablets | GlaxoSmithKline | Division of Drug Marketing, Advertising, and Communications | 3/9/2009 | 4/7/2009 |
Clinical Investigator (Warning Letter)
| Charles J. Cote, M.D. | Division of Scientific Investigations | 3/2/2009 | 3/3/2009 |
Clinical Investigator (Warning Letter)
| Virendra Desai, M.D. | Division of Scientific Investigations | 3/2/2009 | 3/5/2009 |
Clinical Investigator (Warning Letter)
| Manuel J. Quinones, M.D. | Division of Scientific Investigations | 3/3/2009 | 3/5/2009 |
February 2009
| Product/Issue | Company/Individual | Division | Released | Posted |
|---|---|---|---|---|
Avodart (dutasteride) Soft Gelatin Capsules
| GlaxoSmithKline | Division of Drug Marketing, Advertising, and Communications | 2/18/2009 | 2/26/2009 |
Institutional Review Board | SUNY Downstate Medical Center, Health Science Center | Division of Scientific Investigations | 2/11/2009 | 5/5/2010 |
Inspection of Pharmaceutical Manufacturing Facility (Warning Letter)
| Barrie Levitt, M. D. | Division of Manufacturing & Product Quality | 2/5/2009 | 2/5/2009 |
| Clinical Investigator | Christopher Chappel, MD | Division of Scientific Investigations | 2/2/2009 | 2/2/2009 |
| Letairis (ambrisentan) | Gilead Sciences, Inc. | Division of Drug Marketing, Advertising, and Communications | 2/27/2009 | 3/5/2009 |
January 2009
| Product/Issue | Company/Individual | Division | Released | Posted |
|---|---|---|---|---|
Clinical Investigator (Warning Letter)
| Nicola Spirtos, M.D | Division of Scientific Investigations | 1/3/2009 | 1/22/2009 |
| Sponsor-Investigator | George J. Brewer, MD | Division of Scientific Investigations | 1/14/2009 | 1/14/2009 |
| Clinical Investigator | Dr. Lynette Stewart | Division of Scientific Investigations | 1/21/2009 | 1/21/2009 |
| Abbott Laboratories | Division of Drug Marketing, Advertising, and Communications | 1/22/2009 | 1/29/2009 |
| Indevus Pharmaceuticals, Inc. | Division of Drug Marketing, Advertising, and Communications | 1/27/2009 | 1/29/2009 |
Food and Drug Administration
Freedom of Information Staff (HFI-35)
5600 Fishers Lane, Rockville, MD 20857
Instructions for how to submit an FOI request can be found on the FDA FOI Page.
The letters are arranged in chronological order by month. Click on the product name to view the letters in Adobe Acrobat (PDF) format.
