Safety

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

Medical Devices

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

Special Nutritional Products and Cosmetics

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

Biologics (CBER):

Product Name	Date Issued/Updated
Rotavirus, Live, Oral, Pentavalent vaccine (RotaTeq) June 2007	06/15/2007
Rotavirus, Live, Oral, Pentavalent vaccine (RotaTeq) February 2007	02/13/2007

Safety

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Resources for You

2007 Safety Alerts for Human Medical Products

Drugs and Therapeutic Biological Products (CDER)

Medical Devices

Special Nutritional Products and Cosmetics

Biologics (CBER):