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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
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