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2007 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
Accutane (isotretinoin) [ARCHIVED] 03/28/2007
Actimmune (Interferon Gamma 1-b) [ARCHIVED] 03/09/2007
Actos (pioglitazone) [ARCHIVED] 03/09/2007
ACTOplus met (pioglitazone and metformin hydrochloride) [ARCHIVED] 03/09/2007
Age Intervention Eyelash [ARCHIVED] 11/19/2007
Ambien (zolpidem tartrate) [ARCHIVED] 02/16/2007
Ambien, Ambien CR (zolpidem tartate) [ARCHIVED] 03/14/2007
Antidepressant Medication Products [ARCHIVED] 05/02/2007
Aprotinin Injection (marketed as Trasylol) [ARCHIVED] 10/25/2007
Aranesp (darbepoetin alfa) January 2007 [ARCHIVED] 01/27/2007
Aranesp (darbepoetin alfa) February 2007 [ARCHIVED] 03/09/2007
Ativan (lorazepam) [ARCHIVED] 02/16/2007
Avandia (rosiglitazone maleate) Tablets November 2007 [ARCHIVED] 11/14/2007
Avandia (rosiglitazone maleate) Tablets August 2007 [ARCHIVED] 08/14/2007
Actos (pioglitazone hydrochloride) Tablets [ARCHIVED] 08/14/2007
Avandaryl (rosiglitazone maleate and glimepiride) Tablets [ARCHIVED] 08/14/2007
Avandamet (rosiglitazone maleate and metformin hydrochloride) Tablets [ARCHIVED] 08/14/2007
Avandamet (rosiglitazone maleate and metformin hydrochloride) [ARCHIVED] 02/20/2007
Avandaryl (rosiglitazone maleate and glimepiride) [ARCHIVED] 02/20/2007
Avandia (rosiglitazone) [ARCHIVED] 05/21/2007
Avandia (rosiglitazone maleate) February 2007 [ARCHIVED] 02/20/2007
Avastin (bevacizumab) April 2007 [ARCHIVED] 04/21/2007
Baraclude (entecavir) Tablets and Oral Solution [ARCHIVED] 02/24/2007
Bisphosphonates marketed as Alendronate (Fosamax, Fosamax Plus D), Etidronate (Didronel), Ibandronate (Boniva), Pamidronate (Aredia), Risedronate (Actonel, Actonel W/Calcium), Tiludronate (Skelid), and Zoledronic acid (Reclast, Zometa) [ARCHIVED] 10/01/2007
Butisol Sodium Carbrital (pentobarbital and carbromal) [ARCHIVED] 03/14/2007
Byetta (exenatide) October 2007 [ARCHIVED] 08/18/2008
Caffeine Citrated, Powder, Purified May 2007 [ARCHIVED] 05/21/2007
Carbamazepine (marketed as Carbatrol, Equetro, Tegreto and generics) [ARCHIVED] 12/12/2007
Cefepime (marketed as Maxipime) November 2007 [ARCHIVED] 05/14/2008
CellCept (mycophenolate mofetil) February 2007 [ARCHIVED] 02/22/2007
CellCept (mycophenolate mofetil) October 2007 [ARCHIVED] 10/29/2007
Chantix (Varenicline) November 2007 [ARCHIVED] 11/20/2007
Cialis (tadalafil) October 2007 [ARCHIVED] 10/18/2007
Codeine Products Used By Nursing Mothers August 2007 [ARCHIVED] 08/17/2007
Colchicine Compounded Injectable Products May 2007 [ARCHIVED] 05/02/2007
Colistimethate (marketed as Coly-Mycin M and generic products) June 2007 [ARCHIVED] 06/28/2007
Combivir (lamivudine and zidovudine) Tablets [ARCHIVED] 04/10/2007
Cough and Cold Medications in Children Less Than Two Years of Age January 2007 [ARCHIVED] 01/12/2007
Dalmane (flurazepam hydrochloride) [ARCHIVED] 03/14/2007
Desmopressin Acetate (marketed as DDAVP Nasal Spray, DDAVP Rhinal Tube, DDAVP, DDVP, Minirin, and Stimate Nasal Spray) December 2007 [ARCHIVED] 12/04/2007
Diprivan (propofol) [ARCHIVED] 06/15/2007
Doral (quazepam) [ARCHIVED] 03/14/2007
Duetact (pioglitazone hydrochloride and glimepride) Tablets August 2007 [ARCHIVED] 08/14/2007
Duetact (pioglitazone and glimepiride) [ARCHIVED] 03/09/2007
Energy Max [ARCHIVED] 05/10/2007
Epogen (epoetin alfa) [ARCHIVED] 03/09/2007
Ergotamine tartrate March 2007 [ARCHIVED] 03/02/2007
Erythropoiesis Stimulating Agents: Aranesp (darbepoetin alfa), Epogen (epoetin alfa), and Procrit (epoetin alfa) November 2007 [ARCHIVED] 11/08/2007
Erythropoiesis Stimulating Agents February 2007 [ARCHIVED] 02/16/2007
Exjade (deferasirox) Tablets For Oral Suspension [ARCHIVED] 05/22/2007
Fentanyl Transdermal System (marketed as Duragesic and generics) [ARCHIVED] 12/21/2007
Fentora (fentanyl buccal tablet) [ARCHIVED] 09/13/2007
Gadolinium-containing Contrast Agents for Magnetic Resonance Imaging (MRI): Magnevist, MultiHance, Omniscan, OptiMARK, ProHance [ARCHIVED] 05/23/2007
Glycerin compounded products May 2007 [ARCHIVED] 05/07/2007
Grifulvin V (griseofulvin) Oral Suspension, Griseofulvin Oral Suspension [ARCHIVED] 04/10/2007
Guaifenesin (Unapproved) Timed-Release Drug Products [ARCHIVED] 05/25/2007
Halcion (triazolam) [ARCHIVED] 03/14/2007
Haloperidol (Haldol, Haldol decanoate, and Haldol lactate) [ARCHIVED] 09/17/2007
Heparin Sodium Injection 10,000 units/mL, and HEP-LOCK U/P 10 units/mL Medication Errors February 2007 [ARCHIVED] 02/07/2007
Hydrocodone in Unapproved Prescription Products [ARCHIVED] 09/28/2007
Invanz (ertapenem sodium) Injection [ARCHIVED] 07/05/2007
Kaletra (lopinavir/ritonavir) Oral Solution [ARCHIVED] 08/14/2007
Ketek (telithromycin) [ARCHIVED] 02/12/2007
Levitra (vardenafil) [ARCHIVED] 10/18/2007
Lexapro (escitalopram oxalate) [ARCHIVED] 02/16/2007
Lucentis (ranibizumab injection) [ARCHIVED] 02/01/2007
Lunesta (eszopiclone) [ARCHIVED] 03/14/2007
Micro-bubble Contrast Agents (marketed as Definity (Perflutren Lipid Microsphere) Injectable Suspension and Optison (Perflutren Protein-Type A Microspheres for Injection) October 2007 [ARCHIVED] 10/12/2007
Myfortic (mycophenolic acid) Delayed Release Tablets [ARCHIVED] 11/27/2007
NC Solution (antifungal product) [ARCHIVED] 11/01/2007
Nexium (esomeprazole) [ARCHIVED] 08/09/2007
Nonoxynol 9 (N9) OTC Contraceptive Products [ARCHIVED] 12/18/2007
Nonprescription Cough and Cold Medicine Use in Children [ARCHIVED] 08/15/2007
Omeprazole (marketed as Prilosec and generic products) [ARCHIVED] 08/09/2007
Omeprazole + Sodium Bicarbonate (marketed as Zegerid) [ARCHIVED] 08/09/2007
OxyContin, Illegal Promotion by Manufacturer [ARCHIVED] 05/10/2007
Permax (pergolide) and generic equivalents [ARCHIVED] 03/29/2007
PharmaFab Inc., manufacturer and distributor of prescription and over-the-counter drug products [ARCHIVED] 04/25/2007
Placidyl (ethchlorvynol) [ARCHIVED] 03/14/2007
Procrit (epoetin alfa) February 2007 [ARCHIVED] 02/16/2007
Propofol (marketed as Diprivan and generic products) June 2007 [ARCHIVED] 06/15/2007
Prosom (estazolam) [ARCHIVED] 03/14/2007
Provigil (modafinil) Tablets [ARCHIVED] 10/24/2007
Restoril (temazepam) [ARCHIVED] 03/14/2007
Revatio (sildenafil) [ARCHIVED] 10/18/2007
Rocephin (ceftriaxone sodium) for Injection [ARCHIVED] 07/05/2007
Rozerem (ramelteon) [ARCHIVED] 03/14/2007
Seconal (secobarbital sodium) [ARCHIVED] 03/14/2007
Sonata (zaleplon) [ARCHIVED] 03/14/2007
Sedative-hypnotic drug products March 2007 [ARCHIVED] 03/14/2007
Tamiflu (oseltamivir phosphate) January 2007 [ARCHIVED] 01/04/2007
Topical Anesthetic Drugs for Cosmetic Procedures [ARCHIVED] 02/06/2007
Trasylol (aprotinin injection) November 2007 [ARCHIVED] 11/05/2007
Trimethobenzamide hydrochloride suppositories [ARCHIVED] 04/06/2007
True Man [ARCHIVED] 05/10/2007
Viagra (sildenafil) [ARCHIVED] 10/18/2007
Viracept (nelfinavir mesylate) [ARCHIVED] 09/10/2007
Warfarin (marketed as Coumadin) [ARCHIVED] 08/16/2007
Warning About Counterfeit Drugs From Multiple Internet Sellers [ARCHIVED] 05/01/2007
Xanax (alprazolam) [ARCHIVED] 02/16/2007
Xolair (omalizumab) [ARCHIVED] 02/21/2007
Zanaflex (tizanidine hydrochloride) Tablets and Capsules [ARCHIVED] 04/11/2007
Zelnorm (tegaserod maleate) [ARCHIVED] 03/30/2007
Ziagen (abacavir sulfate) Tablets April 2007 [ARCHIVED] 04/10/2007
Zyvox (linezolid) [ARCHIVED] 03/16/2007

Medical Devices

Product NameDate Issued/Updated
Abbott Blood Glucose Meters [ARCHIVED] 09/11/2007
Abbott Laboratories Architect Stat Troponin-1 Immunoassay [ARCHIVED] 06/08/2007
Advanced Medical Optics Complete MoisturePLUS Multipurpose Contact Lens Solution [ARCHIVED] 05/29/2007
Alcon Refractive Horizons LADAR6000 Excimer Laser System [ARCHIVED] 06/05/2007
Baxter Healthcare Corporation COLLEAGUE And FLO-GARD Volumetric Infusion Pumps [ARCHIVED] 07/27/2007
Baxter Healthcare Upgraded COLLEAGUE Triple Channel Volumetric Infusion Pumps [ARCHIVED] 07/20/2007
Bayer Ascensia Contour Blood Glucose Monitoring System [ARCHIVED] 07/13/2007
Bayer Diabetes Care Contour Test Strips (TS) [ARCHIVED] 12/26/2007
B. Braun Medical Inc. Normal Saline Flush Syringes [ARCHIVED] 09/14/2007
Boston Scientific/Guidant CONTAK RENEWAL 3 and 4, VITALITY, and VITALITY 2 implantable cardiac defibrillators and cardiac resynchronization therapy defibrillators [ARCHIVED] 04/12/2007
Cardinal Health Alaris Pump Module [ARCHIVED] 12/26/2007
Cleaners and Disinfectants: Hazards of Excess Use on Electronic Medical Equipment [ARCHIVED] 11/01/2007
Cochlear Implants [ARCHIVED] 10/10/2007
Custom Ultrasonics System 83 Plus and System 83 Plus Mini-flex Washer/Disinfector [ARCHIVED] 02/07/2007
Davol/Bard Composix Kugel Large Sized Patch, Recall and Market Withdrawal [ARCHIVED] 01/12/2007
Defibtech Lifeline and ReviveR Automated External Defibrillators [ARCHIVED] 03/07/2007
Electric Dental Handpieces [ARCHIVED] 12/13/2007
Gebauer Salivart Oral Moisturizer [ARCHIVED] 03/05/2007
Heparin Lock Flush Solution (Pre-Filled 5 ml in 12 ml Syringes) [ARCHIVED] 12/21/2007
Heparin Sodium Injection 10,000 units/mL, and HEP-LOCK U/P 10 units/mL Medication Errors [ARCHIVED] 02/07/2007
HoMedics Heating Pads [ARCHIVED] 02/09/2007
Integra LifeSciences EnDura No-React Dural Substitute [ARCHIVED] 05/25/2007
Medical Equipment That Uses or Displays Time [ARCHIVED] 02/01/2007
Medtronic Sprint Fidelis Defibrillator Leads [ARCHIVED] 10/16/2007
Welch Allyn AED 10 Automatic External Defibrillators [ARCHIVED] 11/02/2007
MRL/Welch Allyn AED 20 Automatic External Defibrillators [ARCHIVED] 09/18/2007
Ortho-Clinical Diagnostics Vitros Immunodiagnostic Products Troponin I Reagent Pack [ARCHIVED] 05/07/2007
Radio Frequency Ablation Devices December 2007 [ARCHIVED] 12/12/2007
ResMed S8 Flow Generators (Continuous Positive Air Pressure or CPAP): S8 Compact, S8 Escape, S8 Elite, and S8 AutoSet Vantage [ARCHIVED] 04/24/2007
Shelhigh, Inc. Implantable Medical Devices [ARCHIVED] 04/18/2007
Smith & Nephew RF Denervation Probes [ARCHIVED] 03/27/2007
Thoratec Implantable Ventricular Assist Devices [ARCHIVED] 11/16/2007
Thoratec Paracorporeal Ventricular Assist System (PVAD) [ARCHIVED] 07/27/2007
Thoratec TLC-II Portable Ventricular Assist Device (VAD) Driver [ARCHIVED] 07/27/2007
Vail Products Enclosed Bed Systems [ARCHIVED] 12/04/2007
Vapotherm 2000i (Respiratory Gas Humidifier System) [ARCHIVED] 02/01/2007

Special Nutritional Products and Cosmetics

Product NameDate Issued/Updated
Abbott Similac Special Care 24 Cal/fl. oz. Ready-to-Feed Premature Infant Formula with Iron [ARCHIVED] 05/29/2007
Axcil Dietary Supplement [ARCHIVED] 09/21/2007
Baby's Bliss Gripe Water, Apple flavor [ARCHIVED] 09/21/2007
Cholestrix [ARCHIVED] 08/09/2007
DermaFreeze365 Products [ARCHIVED] 03/28/2007
Desirin Dietary Supplement [ARCHIVED] 09/21/2007
Encore Supplement Tablets [ARCHIVED] 11/26/2007
Liviro3 [ARCHIVED] 01/25/2007
Long Weekend Dietary Supplement [ARCHIVED] 06/15/2007
METABOLISM Apple Cider Vinegar Brand Dietary Supplement Capsules [ARCHIVED] 08/21/2007
NBTY Shark Cartilage Capsules [ARCHIVED] 05/17/2007
Red Yeast Rice [ARCHIVED] 08/09/2007
Red Yeast Rice/Policosonal Complex [ARCHIVED] 08/09/2007
Rhino Max (Rhino V Max) supplement product [ARCHIVED] 03/16/2007
Super Shangai, Strong Testis, Shangai Ultra, Shangai Ultra X, Lady Shangai, Shangai Regular (also known as Shangai Chaojimengnan) [ARCHIVED] 12/31/2007
Toothpaste Imported From China May Contain Diethylene Glycol [ARCHIVED] 06/01/2007
V.MAX supplement product [ARCHIVED] 03/19/2007
Zencore Tabs [ARCHIVED] 09/07/2007

Biologics (CBER):

Product NameDate Issued/Updated
Rotavirus, Live, Oral, Pentavalent vaccine (RotaTeq) June 2007 [ARCHIVED] 06/15/2007
Rotavirus, Live, Oral, Pentavalent vaccine (RotaTeq) February 2007 [ARCHIVED] 02/13/2007

Page Last Updated: 12/30/2014
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