2006 Safety Alerts for Human Medical Products

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Drugs and Therapeutic Biological Products (CDER)

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

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Medical Devices

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

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Biologics (CBER)

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

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Special Nutritional Products and Cosmetics

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

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2006 Safety Alerts for Human Medical Products

Drugs and Therapeutic Biological Products (CDER)

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Biologics (CBER)

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