Drugs and Therapeutic Biological Products

Product Name	Date Issued/Updated
Actos (pioglitazone): Ongoing Safety Review - Potential Increased Risk of Bladder Cancer	06/15/2011
Advair Diskus (fluticasone propionate and salmeterol inhalation powder): Stolen Product Warning	07/16/2010
Alli 60 mg capsules (120 count refill kit): Counterfeit Product	01/23/2010
Angiotensin Receptor Blockers (ARBs): Drug Safety Communication - Drug Safety Review Completed	06/02/2011
Anzemet (dolasetron mesylate): Drug Safety Communication - Reports of Abnormal Heart Rhythms	12/17/2010
Arava (leflunomide): Boxed Warning - Risk of Severe Liver Injury	07/13/2010
Aromatase Inhibitors in Products Marketed as Dietary Supplements: Recall	10/08/2010
Arrow Brand Medicated Oil and Embrocation: Consumer Warning, Product Considered Toxic	05/28/2010
Avandia (rosiglitazone): REMS - Risk of Cardiovascular Events	11/04/2011
Avandia (rosiglitazone): Ongoing Review of Cardiovascular Safety	02/22/2010
Avastin (bevacizumab): Process for Removal of Breast Cancer Indication Begun	12/16/2010
Benadryl Extra Strength Itch Stopping Gel: Packaging Changes to Reduce Use Errors	05/12/2010
Benicar (olmesartan): Ongoing Safety Review	04/14/2011
Bisphosphonates (Osteoporosis Drugs): Label Change - Atypical Fractures Update	10/13/2010
Camolyn eye drops, Fisiolin nasal drops: Voluntary recall due to non-sterility	04/07/2010
Chelation Products: Unapproved Over-the-Counter Drugs - Consumer Warning	10/14/2010
Coumadin 1 mg Tablet Blister Packs: Recall	07/14/2010
Cubicin (daptomycin): Drug Safety Communication - Risk of Eosinophilic Pneumonia	07/29/2010
Dexamethasone Sodium Phosphate Injection, 4 mg/mL, 30 mL Multiple Dose Vial: Recall due to Particulates in Product	12/24/2010
Epogen and Procrit (epoetin alfa): Recall - Particulate Matter in Vials	09/24/2010
Erythropoiesis-Stimulating Agents (ESAs): Procrit, Epogen and Aranesp: Drug Safety Communication	02/16/2010
Evamist (estradiol transdermal spray): Drug Safety Communication - Unintended Exposure of Children and Pets to Topical Estrogen	07/29/2010
Exjade (deferasirox): Boxed Warning	02/18/2010
Fentanyl Transdermal System: Recall - Potential for Active Ingredient to Release Faster Than Specified	11/05/2010
Gadolinium-based Contrast Agents: Class Labeling Change - Risk of Nephrogenic Systemic Fibrosis	09/09/2010
GnRH Agonists: Label Change - Increased Risk of Diabetes and Cardiovascular Disease (Update)	10/20/2010
GnRH Agonists: Safety Review of Drug Class Used to Treat Prostate Cancer	05/03/2010
Heparin Sodium (B. Braun): Recall - Trace Contaminant	10/29/2010
Heparin: Change in Reference Standard	04/07/2010
Hospira Brand Liposyn and Propofol: Recall	06/10/2010
Hyland’s Teething Tablets: Recall - Risk of Harm to Children	10/24/2010
Hylenex recombinant (hyaluronidase human injection): Recall	05/26/2010
Intravenous Medications Manufactured by Claris: Recall due to contamination of products	05/29/2010
Invirase (saquinavir): Label Change - Risk of Abnormal Heart Rhythm	10/21/2010
Invirase (saquinavir): Ongoing safety review of clinical trial data	02/23/2010
Lamictal (lamotrigine): Label Change - Risk of Aseptic Meningitis	08/12/2010
Lipitor (atorvastatin) 40 mg: Recall Specific Bottles	12/23/2010
Long-Acting Beta-Agonists (LABAs): New Safe Use Requirements	04/15/2011
Maalox Total Relief and Maalox Liquid Products: Medication Use Errors	02/17/2010
McNeil Consumer Healthcare Over-the-Counter Infants’ and Children’s Products: Recall	04/30/2010
McNeil Consumer Healthcare Over-The-Counter Products: Recall	07/08/2010
Meridia (sibutramine): Market Withdrawal Due to Risk of Serious Cardiovascular Events	10/08/2010
Meridia (sibutramine hydrochloride): Follow-Up to an Early Communication about an Ongoing Safety Review	01/21/2010
Methotrexate Injection, 50mg/2mL and 250mg/10mL Vials: Recall - Presence of Glass Particulates	10/29/2010
Metronidazole injection 500 mg / 100 ml: Voluntary recall due to non-sterility	05/17/2010
Midodrine hydrochloride: FDA Proposes Withdrawal of Low Blood Pressure Drug	08/16/2010
Mylotarg (gemtuzumab ozogamicin): Market Withdrawal	06/21/2010
Needleless Pre-filled Glass Syringes: Stakeholder Advisory - Compatibility Problems with Needleless Intravenous Access Systems	05/06/2011
NeoProfen (ibuprofen lysine) Injection: Recall and Shortage - Risk of Particulate Matter	08/02/2010
Nimodipine Oral Capsules: Medication Errors - IV Administration May Result in Death, Serious Harms	08/02/2010
Oral Bisphosphonates: Ongoing Safety Review of Atypical Subtrochanteric Femur Fractures	03/11/2010
Orlistat (marketed as Alli and Xenical): Labeling Change	05/26/2010
PediaCare Children's Products [Blacksmith Brand]: Recall of four products	05/29/2010
Plavix (clopidogrel): Reduced effectiveness in patients who are poor metabolizers of the drug	03/12/2010
Promacta (eltrombopag): Portal Venous System Thromboses in Study of Patients With Chronic Liver Disease	05/12/2010
Propoxyphene: Withdrawal - Risk of Cardiac Toxicity	11/19/2010
Propylthiouracil	04/21/2010
Proton Pump Inhibitors (PPI): Class Labeling Change	05/25/2010
Qualaquin (quinine sulfate): New Risk Evaluation and Mitigation Strategy - Risk of serious hematological reactions	08/04/2010
Rapamune (sirolimus): Drug Monitoring Recommendations	01/11/2010
Recombinant Human Growth Hormone (somatropin): Ongoing Safety Review - Possible Increased Risk of Death	08/04/2011
Reese Pharmaceutical Company OTC Products: Recall - Mislabeled Guaifenesin Tablets	12/13/2010
Rolaids Extra Strength Softchews, Rolaids Extra Strength plus Gas Softchews, Rolaids Multi-Symptom plus Anti-Gas Softchews: Recall - Foreign Materials in Products	12/14/2010
Sodium Bicarbonate Injection, USP, 7.5% and 8.4%, 50 mL Single Dose Vials - Recall Due to Particulates in Some Vials	12/29/2010
Stalevo (entacapone/carbidopa/levodopa): Ongoing Safety Review	03/31/2010
Stalevo(carbidopa/levodopa and entacapone): Ongoing Safety Review: Possible increased cardiovascular risk	08/20/2010
Tamiflu: Counterfeit Product Sold on Internet	06/17/2010
Tessalon (benzonatate): Drug Safety Communication - Potential for Accidental Ingestion by Children	12/14/2010
Tygacil (tigecycline): Label Change - Increased Mortality Risk	09/01/2010
Tylenol 8 Hour Caplets 50 Count: Recall	10/19/2010
Tysabri (natalizumab): Update of Healthcare Professional Information	04/22/2011
Ultram (tramadol hydrochloride), Ultracet (tramadol hydrochloride/acetaminophen): Label Change	05/25/2010
Valcyte (valganciclovir hydrochloride) Label Change: Possible overdose in pediatric patients	09/15/2010
Velcade (bortezomib): Starting Dose Adjustments for Patients with Hepatic Impairment	01/26/2010
Videx/Videx EC (didanosine): Labeling Revision - Risk of Non-Cirrhotic Portal Hypertension	01/29/2010
Vivitrol (naltrexone for extended-release injectable suspension): Medication Guide Required for Patients	05/04/2010
Zocor (simvastatin): increased risk of muscle injury with high doses	03/19/2010
Zyprexa (olanzapine): Use in Adolescents	01/29/2010

Medical Devices

Product Name	Date Issued/Updated
6 French Engage Introducer Devices by St. Jude Medical: Recall - Potential for Separation of Shaft From Hub	08/13/2010
Abbott Glucose Test Strips: Recall - False Low Blood Glucose Results	02/15/2011
Abiomed AB5000 Circulatory Support System: Class I Recall	03/10/2010
Air- or Gas-Pressurized Spray Devices: Risk of Air or Gas Embolism	07/09/2010
AngioSculpt "EX" PTCA Scoring Balloon Catheter by AngioScore, Inc.: Recall - Risk of Catheter Separation	09/08/2010
Arrow Intra-Aortic Balloon (IAB) Catheter Products: Class 1 Recall - Catheters Can Become Stuck in the Sheath	01/27/2011
BagEasy Manual Resuscitation Devices by Westmed, Inc.: Class 1 Recall	09/15/2010
Baxter Colleague Infusion Pumps: FDA Ordering Recall	12/01/2010
Baxter HomeChoice and HomeChoice PRO Automated Peritoneal Dialysis Systems: Class I Recall	03/03/2010
Baylis Medical Torflex Transseptal Guiding Sheath: Class I Recall	03/11/2010
BD Q-Syte Luer Access Devices: Recall	02/09/2010
Beckman Coulter UniCel DxC Synchron Clinical System – Ion Selective Electrode Flow Cell: Class I Recall	03/11/2010
Becton, Dickinson (BD) Q-Syte Luer Access Split Septum Device: Class I Recall	03/18/2010
Boston Scientific Implantable Cardioverter Defibrillators: Recall	03/19/2010
Cardiac Science Automated External Defibrillators - Powerheart, Cardiovive, NK, Responder models: Class I Recall	04/27/2010
Cardiac Science Automated External Defibrillators (Powerheart, Cardiovive, CardioLife models): Recall	02/09/2010
CareFusion Corporation Alaris PC Units (Model 8015): Recall - Potential for Delay or Interruption of Therapy	10/15/2010
Cepheid Xpert MRSA/SA Blood Culture Assay for Use with the GeneXpert Dx System: Class I Recall	07/02/2010
Combat Application Tourniquets (C-A-T): Suspected Counterfeit Product	08/09/2010
CONSTELLATION Vision System: Recall	07/20/2010
Cook brand Ciaglia Blue Rhino/Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducer Sets and Trays	08/04/2010
Counterfeit Polypropylene Surgical Mesh: Initial Communication	06/08/2010
Covidien Initiates Voluntary Recall of Certain Shiley™ Tracheostomy Tubes	04/24/2010
Defibtech DBP-2800 Battery Packs used in Lifeline AED and ReviveR AED: Recall	06/09/2010
Ear Candles: Risk of Serious Injuries	02/20/2010
Edwards Lifesciences Aquarius Hemodialysis System: Recall	01/29/2010
Electric Dental Handpieces and Electric Oral Bone-cutting Handpieces: Safety Investigation of Patient Burns	09/24/2010
ev3 Endovascular Inc. Trailblazer Support Catheter: Class I Recall	01/05/2010
ev3 NanoCross .014" OTW PTA Dilatation Catheter: Class I Recall - Potential for cracking or breaking	12/28/2010
Excelsior Medical 5 ml Fill in 6 cc Prefilled Saline Flush Syringes: Recall - Potential Loss of Sterility	10/15/2010
Fingerstick Devices to Obtain Blood Specimens: Initial Communication - Risk of Transmitting Bloodborne Pathogens	08/26/2010
Fresenius Kabi LLC, Red Blood Cell (RBC) Exchange Sets used on AS104 Blood Cell Separation Devices: Class I Recall	12/21/2010
GE Healthcare Aisys and Avance Anesthesia Systems: Recall	05/13/2010
Gyrus ACMI Micron Bobbin Vent Tube T: Class I Recall	03/17/2010
Hettich Centrifuges with 2050 and 2076 Plastic Rotors: Recall	01/28/2010
HiRes 90K Cochlear Implant Device: Recall - Malfunction	11/27/2010
Hospira Symbiq One-Channel and Two-Channel Infusers: Class I Recall - Motor Encoder Failures	11/04/2010
Hospira Symbiq One-Channel and Two-Channel Infusers: Class I Recall	09/10/2010
Huber Needles: Recall - Risk of Coring	10/12/2010
Infant Sleep Positioners: Consumer Warning - Risk of Suffocation	09/29/2010
Inferior Vena Cava (IVC) Filters: Initial Communication: Risk of Adverse Events with Long Term Use	08/09/2010
Infusion Set Needles [Manufactured by Nipro for Exelint]: Recall	01/26/2010
INOMAX DS Drug-Delivery System: Class I Recall - Risk of Interruption of Drug Flow	08/23/2010
LIFEPAK 15 Monitor/Defibrillator by Physio-Control Inc.	04/22/2010
LIFEPAK 20 and LIFEPAK 20e External Defibrillator/Monitors by Physio-Control Inc.: Class I Recall Due To Power Supply Failure	07/02/2010
Nipro GlucoPro Insulin Syringes: Recall	01/22/2010
Micromedics, Inc. Surgical Sealant Dispensers, Nasal Septal Buttons, and Otological Ventilation Tubes: Class 1 Recall-Weak or Open Seals	11/23/2010
Octopus Nuvo Tissue Stabilizer: Class I Recall - Potential for Device Fracture	11/01/2010
OneTouch SureStep Test Strips (LifeScan): Recall	02/26/2010
Penumbra System Reperfusion Catheter 032: Class I Recall Due to Manufacturing Error	12/08/2010
Safesheath CSG Coronary Sinus Guide Hemostatic Introducer System with Infusion Sideport by Thomas Medical	02/04/2010
Sigma Spectrum Infusion Pump Model 35700: Class 1 Recall: Risk of Over-Infusion	06/15/2012
StatSpin Express 4 Centrifuges Model 510: Class I Recall	02/26/2010
Teleflex Arrow IV Tubing Sets, Accessories, and Embolectomy Catheters: Recall	04/08/2010
Teleflex Medical AQUA+FLEX Hygroscopic Condenser Humidifier (Catalog Number 1570): Recall	05/06/2010
Thomas Medical Products, Inc., Transseptal Sheath Introducer Kits: Class I Recall	03/05/2010
Triton Pole Mount Infusion Pump by WalkMed: Recall - Potential Door Open Alarm Problem	11/30/2010
VITEK 2 Gram Negative Susceptibility Cards Containing Piperacillin/Tazobactam (TZP): Recall - Incorrect Test Results Observed	11/10/2010

Special Nutritional and Cosmetic Products

Product Name	Date Issued/Updated
HAPPYTOT Stage 4 and HAPPYBABY Stage 1 & Stage 2 Pouch Meals - Recall	01/13/2010
Miracle Mineral Solution (MMS): Product as consumed produces a potent bleach	07/30/2010
Similac Powder Infant Formulas: Recall	09/24/2010
Vita Breath Dietary Supplement	05/03/2010
Vitamin D Supplement Products: Medication Use Error	06/15/2010

Biologics

Product Name	Date Issued/Updated
Afluria (CSL Ltd.) Influenza Virus Vaccine: Label Change - Risk of Fever and Febrile Seizure	07/30/2010
GammaGard Liquid, Immune Globulin Intravenous (Human)	06/04/2010
Octagam (Immune Globulin Intravenous (human)) 5% Liquid Preparation: Market Withdrawal - Risk of Thromboembolic Events	09/24/2010
Rotarix Vaccine: Update to Clinicians and Public Health Professionals	05/16/2010
WinRho SDF (Rho(D) Immune Globulin Intravenous (Human): Risk of Intravascular Hemolysis	03/10/2010

Products With Undeclared Drug Ingredients

Products marketed as dietary supplements, but containing one or more unlisted drug ingredients.

Product Name	Date Issued/Updated
Atlas Operations, Inc.: Recall of Sexual Enhancement Products	04/14/2010
Duro Extend Capsules for Men: Recall - Undeclared Drug Ingredient	12/06/2010
Fruta Planta: Public Notification - Undeclared Drug Ingredient	01/03/2011
Joyful Slim Herb Supplement : Recall-Undeclared Drug Ingredient	07/22/2010
Magic Power Coffee: Undeclared Drug Ingredient	06/21/2010
Man Up Now Capsules: Consumer Warning - Undeclared Drug Ingredient	12/13/2010
MasXtreme Capsules (Natural Wellness) - product contains undeclared drug ingredient	08/25/2010
Mr. Magic Male Enhancer: Undeclared Drug Ingredient	08/24/2010
MuscleMaster.com Products Sold on Internet as Dietary Supplements: Recall	01/15/2010
Novacare LLC Products: Recall - Undeclared Drug Ingredient	08/11/2010
Nutraloid Labs ejaculoid XXTREME and stimuloid II: Undeclared Drug Ingredient	07/30/2010
Prolatis’: Undeclared Drug Ingredient	08/13/2010
Que She Herbal Supplement: Undeclared Drug Ingredients	07/08/2010
Revivexxx Extra Strength: Recall - Undeclared Drug Ingredient	08/09/2010
Rock Hard Extreme and Passion Coffee by Drive Total Energy: Recall - Undeclared Drug Ingredient	01/03/2011
RockHard Weekend, Pandora: Recall - Undeclared Drug Ingredient	12/23/2010
Slim- 30 Herb Supplement: Undeclared Drug Ingredient	07/19/2010
Slimming Beauty Bitter Orange Slimming Capsules: Undeclared Drug Ingredient	10/08/2010
Solo Slim, Solo Slim Extra Strength: Recall - Undeclared Drug Ingredient	08/09/2010
Stud Capsule For Men: Product contains Undeclared Drug Ingredient	04/06/2010
TimeOut Capsules: Undeclared Drug Ingredient	08/25/2010
Vialipro Dietary Supplement: Recall-Undeclared Drug Ingredient	07/20/2010
Vigor-25: Undeclared Drug Ingredient-Sold as natural dietary supplement	11/19/2010