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Safety

2008 Safety Alerts for Human Medical Products

Items in the following lists are in alphabetical order. Click "Date Issued" to re-order the items in a list by date. Click "Product Name" to re-order the items alphabetically.

Special Nutritional Products and Cosmetics

Product NameDate Issued/Updated
Aspire36, Aspire Lite Dietary Supplements [ARCHIVED] 03/04/2008
Blue Steel and Hero Dietary Supplement Products [ARCHIVED] 03/25/2008
Calcilo XD Low-Calcium & Vitamin D-Free Infant Formula With Iron Powder [ARCHIVED] 06/02/2008
Herbal Science International, Inc. Dietary Herbal Supplements [ARCHIVED] 04/14/2008
Infant Formula Manufactured in China [ARCHIVED] 10/03/2008
Rize 2 The Occasion Capsules, Rose 4 Her Capsules [ARCHIVED] 07/30/2008
Total Body Formula, Total Body Mega Formula [ARCHIVED] 05/01/2008
Viapro 375mg Capsules [ARCHIVED] 07/31/2008
Viril-ity Power (VIP) Tablets [ARCHIVED] 05/30/2008
Weight Loss Pills [ARCHIVED] 12/22/2008
Xiadafil VIP Tablets [ARCHIVED] 05/27/2008

Drugs and Therapeutic Biological Products (CDER)

Product NameDate Issued/Updated
2 Percent Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation Product [ARCHIVED] 06/30/2008
20 mEq Potassium Chloride in 5 Percent Dextrose and 0.45 Percent Sodium Chloride Injection, USP [ARCHIVED] 12/09/2008
Abacavir (marketed as Ziagen), Abacavir-containing Medications [ARCHIVED] 07/24/2008
Ammonul (sodium phenylacetate and sodium benzoate) Injection 10 Percent/10 Percent [ARCHIVED] 09/23/2008
Antipsychotics, Conventional and Atypical [ARCHIVED] 06/16/2008
Antiepileptic Drugs [ARCHIVED] 05/05/2009
Avandia (rosiglitazone maleate) [ARCHIVED] 02/26/2008
Avastin (bevacizumab) [ARCHIVED] 07/14/2008
B. Braun Heparin Sodium in 5 Percent Dextrose and 0.9 Percent Sodium Chloride Injection Solution [ARCHIVED] 03/21/2008
Benzoyl Peroxide Acne Cream 10 Percent [ARCHIVED] 11/17/2008
Bisphosphonates marketed as Alendronate (Fosamax, Fosamax Plus D) [ARCHIVED] 11/12/2008
Bisphosphonates (marketed as Actonel, Actonel+Ca, Aredia, Boniva, Didronel, Fosamax, Fosamax+D, Reclast, Skelid, and Zometa) [ARCHIVED] 01/07/2008
Botox, Botox Cosmetic (Botulinum toxin Type A), Myobloc (Botulinum toxin Type B) [ARCHIVED] 02/07/2008
Byetta (exenatide) [ARCHIVED] 08/18/2008
Cardinal Alcohol-Free Mouthwash [ARCHIVED] 05/06/2008
Cefepime (marketed as Maxipime) [ARCHIVED] 05/14/2008
CellCept (mycophenolate mofetil) [ARCHIVED] 02/22/2007
Chantix (varenicline) [ARCHIVED] 10/24/2011
Colchicine, Injectable (including drugs containing colchicine) [ARCHIVED] 02/06/2008
Compounded Menopause Hormone Therapy Drugs [ARCHIVED] 01/10/2009
Cubicin (daptomycin for injection) [ARCHIVED] 04/09/2008
Desmopressin Acetate (marketed as DDAVP Nasal Spray, DDAVP Rhinal Tube, DDAVP, DDVP, Minirin, and Stimate Nasal Spray) [ARCHIVED] 08/07/2008
Dextroamphetamine Sulfate Tablets 10 mg [ARCHIVED] 11/10/2008
Dextroamphetamine Sulfate 5mg Tablets [ARCHIVED] 10/16/2008
Digitek (digoxin tablets, USP) [ARCHIVED] 04/14/2008
Duragesic 25 mcg/hr (fentanyl transdermal system) CII Pain Patches [ARCHIVED] 02/15/2008
Edetate Disodium (marketed as Endrate and generic products) [ARCHIVED] 01/16/2008
Enbrel (etanercept) [ARCHIVED] 05/01/2008
Epoetin alfa - Early Communication about an Ongoing Safety Review [ARCHIVED] 09/23/2008
Erythropoiesis Stimulating Agents (ESAs) - Epoetin alfa (marketed as Procrit, Epogen), Darbepoetin alfa (marketed as Aranesp) [ARCHIVED] 07/31/2008
Erythropoiesis Stimulating Agents: Aranesp (darbepoetin alfa), Epogen (epoetin alfa), and Procrit (epoetin alfa) [ARCHIVED] 03/12/2008
Exubera (insulin human rDNA origin) Inhalation Powder [ARCHIVED] 04/09/2008
Ezetimibe/Simvastatin (marketed as Vytorin, Simvastatin (marketed as Zocor), Ezetimibe (marketed as Zetia) [ARCHIVED] 08/21/2008
Ezetimibe/Simvastatin (marketed as Vytorin), Ezetimibe (marketed as Zetia), and Simvastatin (marketed as Zocor): Early Communication about an Ongoing Data Review [ARCHIVED] 01/25/2008
Fentanyl transdermal System CII Patches [ARCHIVED] 04/19/2008
Fluoroquinolone Antimicrobial Drugs [ARCHIVED] 07/08/2008
Foradil (formoterol fumarate inhalation powder) Capsules [ARCHIVED] 02/29/2008
Fosphenytoin Sodium (marketed as Cerebyx and generics) [ARCHIVED] 11/24/2008
Foradil (formoterol fumarate inhalation powder) Capsules [ARCHIVED] 02/29/2008
Heparin Sodium USP Pre-Filled Syringes [ARCHIVED] 04/02/2008
Heparin Sodium Injection (Feb 2008) [ARCHIVED] 02/11/2008
Heparin Sodium Injection 1000 units/mL 1OmL and 30 mL Vials [ARCHIVED] 01/18/2008
Herceptin 440 mg Vials and BWFI Diluent [ARCHIVED] 07/10/2008
Hydromorphone HCl 2 mg Tablets [ARCHIVED] 12/24/2008
Infants' Mylicon Gas Relief Dye Free Drops (Simethicone-Antigas) [ARCHIVED] 11/12/2008
Innohep (tinzaparin sodium injection) [ARCHIVED] 12/31/2008
Isosorbide Mononitrate Extended Release Tablets 30 mg and 60 mg [ARCHIVED] 11/10/2008
Leukine (sargramostim) [ARCHIVED] 01/24/2008
Long-Acting Hydrocodone-Containing Cough Product (marketed as Tussionex Pennkinetic Extended-Release Suspension) [ARCHIVED] 03/11/2008
Micro-bubble Contrast Agents (marketed as Definity (Perflutren Lipid Microsphere) Injectable Suspension and Optison (Perflutren Protein-Type A Microspheres for Injection) [ARCHIVED] 07/17/2008
Mitoxantrone Hydrochloride (marketed as Novantrone and generics) [ARCHIVED] 07/29/2008
Mommy's Bliss Nipple Cream [ARCHIVED] 05/29/2008
Morphine Sulfate Immediate Release Tablets 15 mg and 30 mg [ARCHIVED] 11/10/2008
Morphine Sulfate Extended Release Tablets 15 mg [ARCHIVED] 11/11/2008
Morphine Sulfate 60 mg Extended Release Tablets [ARCHIVED] 06/10/2008
Mycophenolate Mofetil [MMF] (marketed as CellCept) [ARCHIVED] 05/16/2008
Mycophenolic Acid [MPA] (marketed as Myfortic) [ARCHIVED] 05/16/2008
Neupro (rotigotine transdermal system) [ARCHIVED] 04/09/2008
NuCel Labs Eye Drops and Eye/Ear Wash Products [ARCHIVED] 01/31/2008
Oral Sodium Phosphate (OSP) Products for Bowel Cleansing (marketed as Visicol and OsmoPrep, and oral sodium phosphate products available without a prescription) [ARCHIVED] 12/11/2008
Ortho Evra Contraceptive Transdermal Patch [ARCHIVED] 01/19/2008
Over The Counter Cough and Cold Medications [ARCHIVED] 10/09/2008
Phenytoin (marketed as Dilantin, Phenytek and generics) and Fosphenytoin Sodium (marketed as Cerebyx and generics) [ARCHIVED] 11/24/2008
Phosphocol P 32 (Chromic Phosphate P 32 Suspension) [ARCHIVED] 09/18/2008
Prezista (darunavir) 03/12/2008
Propafenone HCl Tablets 150 mg, 225 mg, and 300 mg [ARCHIVED] 11/10/2008
Raptiva (efalizumab) October 2008 [ARCHIVED] 10/17/2008
Regranex (becaplermin) Gel [ARCHIVED] 06/06/2008
Relenza (zanamivir) [ARCHIVED] 04/01/2008
Rituxan (rituximab) [ARCHIVED] 09/11/2008
Simvastatin Used With Amiodarone [ARCHIVED] 08/08/2008
Singulair (montelukast) [ARCHIVED] 03/27/2008
Sodium Polystyrene Sulfonate Suspension [ARCHIVED] 07/16/2008
Solodyn (minocycline HCL) Extended Release Tablets 90 mg [ARCHIVED] 05/19/2008
Spiriva (tiotropium bromide inhalation powder) Capsules [ARCHIVED] 02/29/2008
Starcaps Dietary Supplement Capsules [ARCHIVED] 11/26/2008
Tamiflu (oseltamivir phosphate) [ARCHIVED] 03/04/2008
Tarceva (erlotinib) [ARCHIVED] 09/23/2008
Tiotropium (marketed as Spiriva HandiHaler) [ARCHIVED] 10/07/2008
Trasylol (aprotinin injection) [ARCHIVED] 05/14/2008
Tumor necrosis factor-alpha blockers (TNF blockers), Cimzia (certolizumab pegol), Enbrel (etanercept), Humira (adalimumab), and Remicade (infliximab) Sept 2008 [ARCHIVED] 09/04/2008
Tumor Necrosis Factor (TNF) Blockers (marketed as Remicade, Enbrel, Humira, and Cimzia) [ARCHIVED] 06/03/2008
Tysabri (natalizumab) [ARCHIVED] 08/25/2008
Tysabri (natalizumab) Feb 2008 [ARCHIVED] 02/27/2008
Unapproved Over The Counter Drugs Marketed for Prevention and Treatment of STDs [ARCHIVED] 03/06/2008
Varenicline (marketed as Chantix) [ARCHIVED] 02/01/2008
Videx (didanosine) and Ziagen (abacavir) [ARCHIVED] 07/24/2008
Vivitrol (naltrexone) [ARCHIVED] 08/12/2008
Weight Loss Pills [ARCHIVED] 12/22/2008
Zhen De Shou Fat Loss Capsules [ARCHIVED] 11/26/2008
Ziagen (abacavir) [ARCHIVED] 03/27/2008

Medical Devices

Product NameDate Issued/Updated
Animas Corporation Battery Caps Used with the OneTouch Ping System, Animas 2020 Insulin Pump, Animas IR1200 Insulin Pump, and Animas IR1250 Insulin Pump [ARCHIVED] 11/20/2008
Blood Glucose Meters and Test Strips [ARCHIVED] 03/11/2008
Boston Scientific NexStent Monorail, NexStent Carotid Stent and Monorail Delivery System [ARCHIVED] 08/14/2008
Chattem Icy Hot Heat Therapy Products [ARCHIVED] 03/11/2008
Cordis Corporation Dura Star RX and Fire Star RX PTCA Balloon Catheters [ARCHIVED] 01/25/2008
Denture Cleanser Allergic Reactions and Misuse [ARCHIVED] 02/26/2008
Disposable Battery Operated Lavage System (BOLS) [ARCHIVED] 09/08/2008
Electronic Medical Devices [ARCHIVED] 07/16/2008
Gravity Compensating Accessory, High Pressure Range, Sterile, Single Use, by Integra NeuroSciences [ARCHIVED] 12/11/2008
Greenline/D MacIntosh No. 3 Laryngoscope Blades [ARCHIVED] 12/19/2008
Healon D Ophthalmic Viscosurgical Device [ARCHIVED] 12/11/2008
Heparin and Normal Saline Pre-Filled Flushes [ARCHIVED] 01/18/2008
Heparin Sodium Injection [ARCHIVED] 02/11/2008
Levitronix CentriMag Extracorporeal Blood Pumping System: CentriMag Primary Console (with v200 Application Software) [ARCHIVED] 08/01/2008
LifePak CR Plus Automated External Defibrillators [ARCHIVED] 09/11/2008
Medtronic AneuRx Stent Graft System [ARCHIVED] 03/18/2008
Medtronic INDURA 1P Intrathecal Catheter, Sutureless Pump Connector Revision Kit, Intrathecal Catheter Pump Segment Revision Kit [ARCHIVED] 10/02/2008
Medtronic Neuromodulation SynchroMed EL, SynchroMed II and IsoMed Implantable Infusion Pumps [ARCHIVED] 03/21/2008
Medtronic SynchroMed EL Implantable Infusion Pump [ARCHIVED] 02/04/2008
Nebion HLX-8 Magnetic Resonance Device [ARCHIVED] 10/03/2008
Pacific Consolidated brand Mobile Oxygen Storage Tank [ARCHIVED] 08/28/2008
Radio Frequency Ablation Devices [ARCHIVED] 09/26/2008
Recombinant Human Bone Morphogenetic Protein in Cervical Spine Fusion [ARCHIVED] 07/02/2008
ReliOn Insulin Syringes for use with U-100 Insulin (Tyco Healthcare - Covidien) [ARCHIVED] 11/06/2008
Stryker Custom Cranial Implant Kits [ARCHIVED] 12/24/2008
Terumo Cardiovascular Systems Tenderflow Pediatric Arterial Cannulae [ARCHIVED] 12/08/2008
Thoratec HeartMate II Left Ventricular Assist System [ARCHIVED] 10/28/2008
Transvaginal Placement of Surgical Mesh [ARCHIVED] 07/13/2011
Unretrieved Device Fragments [ARCHIVED] 01/15/2008
Vibe Technologies Vibrational Integrated Bio-photonic Energizer Machine Multi-Frequency Field Generator [ARCHIVED] 10/31/2008

Page Last Updated: 12/30/2014
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