Archived Content

The content on this page is provided for reference purposes only. This content has not been altered or updated since it was archived.

Safety

2006 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.

Drugs and Therapeutic Biological Products (CDER)

Product NameDate Issued/Updated
5-Hydroxytryptamine Receptor Agonists (Triptans) - Serotonin Syndrome [ARCHIVED] 07/19/2006
Accutane and generic isotretinoin [ARCHIVED] 10/06/2006
Acetaminophen 500 mg Caplets by Perrigo Company [ARCHIVED] 11/09/2006
Anabolic Xtreme Superdrol [ARCHIVED] 03/10/2006
Angiotensin-converting enzyme inhibitor (ACE inhibitors) drug class [ARCHIVED] 06/07/2006
Aptivus (tipranavir) [ARCHIVED] 06/30/2006
Avandamet (rosiglitazone maleate) [ARCHIVED] 01/05/2006
Avandia (rosiglitazone maleate/metformin hcl) [ARCHIVED] 01/05/2006
Avastin (bevacizumab) Sept 2006 [ARCHIVED] 09/25/2006
Azathioprine Tablets, 50 mg [ARCHIVED] 09/25/2006
Benzocaine sprays [ARCHIVED] 02/13/2006
Bismacine/Chromacine [ARCHIVED] 07/21/2006
Cefazolin for Injection [ARCHIVED] 03/01/2006
Clozaril (clozapine) [ARCHIVED] 01/13/2006
Complete MoisturePLUS Contact Lens Care Products [ARCHIVED] 11/22/2006
Compounded topical anesthetic creams [ARCHIVED] 12/06/2006
Coumadin (warfarin sodium) [ARCHIVED] 10/06/2006
Cytosol Laboratories, Inc. Balanced Salt Solution (BSS) [ARCHIVED] 02/14/2006
Dexedrine (dextroamphetamine sulfate) [ARCHIVED] 08/21/2006
Diastat AcuDial (diazepam rectal gel) [ARCHIVED] 03/30/2006
Dolophine (methadone hydrochloride) [ARCHIVED] 11/27/2006
Droxia (hydroxyurea capsules) [ARCHIVED] 01/26/2006
Effexor XR (venlafaxine HCl) Extended-Release Capsules [ARCHIVED] 10/25/2006
Elidel Cream (pimecrolimus) [ARCHIVED] 01/20/2006
Fleet Phospho-Soda and Fleet Accu-Prep [ARCHIVED] 05/05/2006
Gadolinium-containing Contrast Agents for Magnetic Resonance Imaging (MRI): Omniscan, OptiMARK, Magnevist, ProHance, and MultiHance [ARCHIVED] 12/22/2006
Gleevec (imatinib mesylate) [ARCHIVED] 10/19/2006
Goldline Brand Extra Strength Genapap and Extra Strength Genebs (Acetaminophen 500 mg) [ARCHIVED] 05/03/2006
Heartland Repack Services products [ARCHIVED] 10/25/2006
Heparin Sodium Injection [ARCHIVED] 12/08/2006
High-Strength Hydrogen Peroxide [ARCHIVED] 07/27/2006
Hydralazine HCl Injection, USP, 20 mg/mL [ARCHIVED] 08/25/2006
Hydrea (hydroxyurea capsules) [ARCHIVED] 01/26/2006
Ibuprofen and Aspirin Taken Together [ARCHIVED] 09/08/2006
Isotretinoin - Accutane and generic isotretinoin [ARCHIVED] 10/06/2006
Illegal Steroid Products Sold as Dietary Supplements [ARCHIVED] 03/10/2006
Ketek (telithromycin) 06/29/2006 [ARCHIVED] 06/29/2006
Ketek (telithromycin) 01/20/2006 [ARCHIVED] 01/20/2006
Lamictal (lamotrigine) [ARCHIVED] 09/29/2006
Macugen (pegaptanib sodium injection) [ARCHIVED] 04/07/2006
Methadone Hydrochloride (dolophine) [ARCHIVED] 11/27/2006
Methyl-1-P [ARCHIVED] 03/10/2006
Mifeprex (mifepristone) [ARCHIVED] 03/17/2006
NeutraGard 0.05% and NeutraGard Plus 0.2% Neutral Sodium Fluoride Anticavity Treatment Rinse [ARCHIVED] 04/28/2006
Nimotop (nimodipine) [ARCHIVED] 02/15/2006
Ontak (denileukin diftitox) [ARCHIVED] 03/15/2006
Oral Sodium Phosphate (OSP) Products for Bowel Cleansing [ARCHIVED] 05/05/2006
Ortho Evra (norelgestromin/ethinyl estradiol) [ARCHIVED] 09/20/2006
Osmoprep Tablets [ARCHIVED] 05/05/2006
Paxil (paroxetine hydrochloride) Tablets and Oral Suspension [ARCHIVED] 05/12/2006
Promethazine HCl (marketed as Phenergan and generic products) [ARCHIVED] 04/25/2006
Protopic Ointment (tacrolimus) [ARCHIVED] 01/20/2006
Quinine products [ARCHIVED] 12/12/2006
Rituxan (Rituximab) [ARCHIVED] 12/18/2006
Selective Serotonin/Norepinephrine Reuptake Inhibitors (SNRIs) [ARCHIVED] 07/19/2006
SSRIs and Treatment Challenges of Depression in Pregnancy [ARCHIVED] 07/19/2006
Selective Serotonin Reuptake Inhibitors (SSRIs) [ARCHIVED] 07/19/2006
Tacrolimus Active Pharmaceutical Ingredient [API] [ARCHIVED] 05/18/2006
Tamiflu (oseltamivir phosphate) [ARCHIVED] 11/13/2006
Tequin (gatifloxacin) [ARCHIVED] 02/16/2006
Tracleer (bosentan) [ARCHIVED] 03/02/2006
Trasylol (aprotinin) [ARCHIVED] 12/15/2006
Triaminic Vapor Patch [ARCHIVED] 06/20/2006
Tysabri (natalizumab) [ARCHIVED] 07/21/2006
Ultravist (iopromide) Injection 370mgl/mL, 125 mL [ARCHIVED] 07/31/2006
Unapproved Compounded Inhalation Drugs [ARCHIVED] 08/10/2006
Visicol Tablets [ARCHIVED] 05/05/2006
WellPatch Cough & Cold Soothing Vapor Pads [ARCHIVED] 08/01/2006

Medical Devices

Product NameDate Issued/Updated
Alaris SE Infusion Pumps [ARCHIVED] 09/26/2006
At-Home Genetic Tests [ARCHIVED] 07/31/2006
Baxter Healthcare Corp. COLLEAGUE Volumetric Infusion Pumps and Syndeo Patient Controlled Analgesic Syringe Pump [ARCHIVED] 07/07/2006
Baxter Healthcare Corp. COLLEAGUE and COLLEAGUE CX Volumetric Infusion Pumps 04/28/2006 [ARCHIVED] 04/28/2006
Baxter Healthcare Corp. COLLEAGUE and COLLEAGUE CX Volumetric Infusion Pumps 02/02/2006 [ARCHIVED] 02/02/2006
Blackstone Medical ICON Modular Fixation System [ARCHIVED] 04/18/2006
Boca Medical Ultilet and Closercare Insulin Syringes [ARCHIVED] 05/23/2006
Boca Medical Ultilet Insulin Syringe 30g 1/2cc [ARCHIVED] 04/17/2006
Boston Scientific Flextome Cutting Balloon Systems [ARCHIVED] 02/02/2006
Boston Scientific Mach 1 Guide Catheters [ARCHIVED] 12/22/2006
Cochlear Implants with a Positioner [ARCHIVED] 02/06/2006
Davol/Bard Composix Kugel Mesh Patch [ARCHIVED] 03/31/2006
Disetronic D-TRONplus Power Packs used in D-TRONplus Insulin Pumps [ARCHIVED] 09/20/2006
Disetronic Medical Systems, Inc. ACCU-CHEK Ultraflex Infusion Sets [ARCHIVED] 07/24/2006
Fungal Keratitis Infections Related to Contact Lens Use [ARCHIVED] 05/31/2006
Gambro Prisma Continuous Renal Replacement System [ARCHIVED] 03/01/2006
Guidant CONTAK RENEWAL TR/TR2 Cardiac Resynchronization Therapy Pacemakers [ARCHIVED] 07/11/2006
Guidant INSIGNIA and NEXUS Pacemakers [ARCHIVED] 07/11/2006
Guidant VENTAK PRIZM 2, VITALITY and VITALITY 2 Implantable Cardioverter Defibrillators [ARCHIVED] 07/11/2006
Hamilton Medical, Inc. RAPHAEL Ventilators [ARCHIVED] 06/12/2006
Hospital Bed Entrapments [ARCHIVED] 03/09/2006
LifeScan One Touch Blood Glucose Test Strips -- Counterfeit Alert [ARCHIVED] 03/12/2007
Medtronic Model 8731 Intrathecal Catheter and Model 8598 Intrathecal Catheter Distal Revision Kit [ARCHIVED] 09/08/2006
Ortho VITROS Immunodiagnostic HBsAg Confirmatory Kit [ARCHIVED] 01/09/2006
Ortho-Clinical Diagnostics VITROS Immunodiagnostic Products Signal Reagent [ARCHIVED] 04/18/2006
Ossur Total Knee prosthetic device [ARCHIVED] 03/31/2006
Oxygen Regulator Fires Resulting from Incorrect Use of CGA 870 Seals [ARCHIVED] 06/20/2006
Reprocessing of Reusable Ultrasound Transducer Assemblies Used for Biopsy Procedures [ARCHIVED] 06/20/2006
Respironics PLV Continuum Ventilator (PLVC I) [ARCHIVED] 05/05/2006
Roche Diagnostics ACCU-CHEK Aviva Meters [ARCHIVED] 01/19/2006
Roche Diagnostics CoaguChek PT Test Strips [ARCHIVED] 10/20/2006
Sage Products Inc. Comfort Shield Perineal Care Washcloths [ARCHIVED] 06/26/2006
Steris Amsco Sonic Energy Cleaner and Amsco Sonic Energy Console [ARCHIVED] 08/31/2006
The First Years Liquid-Filled Teethers [ARCHIVED] 01/30/2006
Ultravist (iopromide) Injection 370mgl/mL, 125 mL [ARCHIVED] 07/31/2006
Vapotherm 2000i and 2000h Respiratory Gas Humidifier [ARCHIVED] 01/30/2006
Welch Allyn AED20 Automatic External Defibrillators [ARCHIVED] 06/16/2006
Welch Allyn PIC 50 Automated External Defibrillators [ARCHIVED] 07/07/2006

Biologics (CBER)

Product NameDate Issued/Updated
Human tissue recovered by Biomedical Tissue Services, Ltd. (BTS) [ARCHIVED] 03/02/2006
Human Tissues recovered by Donor Referral Services (DRS) [ARCHIVED] 08/31/2006
Menactra (Meningococcal Conjugate Vaccine A, C, Y, and W135) [ARCHIVED] 10/23/2006
WinRho SDF (Rho(D) Immune Globulin Intravenous [Human]) [ARCHIVED] 01/06/2006

Special Nutritional Products and Cosmetics

Product NameDate Issued/Updated
Advanced Arthritis Support Capsules [ARCHIVED] 09/07/2006
Anabolic Xtreme Superdrol [ARCHIVED] 03/10/2006
Brazilian Diet Pills (Emagrece Sim and Herbathin products) [ARCHIVED] 01/13/2006
Coral Max Capsules, Coral Max without Iron Capsules [ARCHIVED] 09/07/2006
Dietary Supplements Containing Ephedrine Alkaloids [ARCHIVED] 08/22/2006
Dietary Supplements Promoted for Sexual Enhancement [ARCHIVED] 07/13/2006
Ellagimax Capsules [ARCHIVED] 09/07/2006
Mead Johnson GENTLEASE powdered infant formula [ARCHIVED] 02/22/2006
Methyl- 1-P [ARCHIVED] 03/10/2006

Page Last Updated: 12/30/2014
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.