FDA Alerts Archive for 2008

January 7, 2008

• Bisphosphonates (marketed as Actonel, Actonel+Ca, Aredia, Boniva, Didronel, Fosamax, Fosamax+D, Reclast, Skelid, and Zometa)

January 10, 2008

• Compounded Menopause Hormone Therapy Drugs

January 15, 2008

• Unretrieved Device Fragments

January 16, 2008

• Edetate Disodium (marketed as Endrate and generic products)

January 17, 2008

• Cough and Cold Medications in Children Less Than Two Years of Age - Jan 17, 2008

January 18, 2008

• Heparin and Normal Saline Pre-Filled Syringe Flushes

January 19, 2008

• Ortho Evra Contraceptive Transdermal Patch
• Heparin Sodium Injection 1000 units/mL 1OmL and 30 mL Vials

January 24, 2008

• Leukine (sargramostim)

January 25, 2008

• Ezetimibe/Simvastatin (marketed as Vytorin), Ezetimibe (marketed as Zetia), and Simvastatin (marketed as Zocor)
• Cordis Corporation Dura Star RX and Fire Star RX PTCA Balloon Catheters

January 31, 2008

• NuCel Labs Eye Drops and Eye-Ear Wash Products

February 1, 2008

• Varenicline (marketed as Chantix)

February 4, 2008

• Medtronic SynchroMed EL Implantable Infusion Pump

February 6, 2008

• Injectable Colchicine (including drugs containing colchicine)

February 8, 2008

• Botox, Botox Cosmetic (Botulinum toxin Type A), Myobloc (Botulinum toxin Type B)

February 11, 2008

• Heparin Sodium Injection (Baxter)
• Chattem Icy Hot Heat Therapy Products

February 15, 2008

• Duragesic 25 mcg/hr (fentanyl transdermal system) CII Pain Patches

February 19, 2008

• Fentanyl transdermal system CII Patches

February 26, 2008

• Denture Cleanser Allergic Reactions and Misuse
• Avandia (rosiglitazone maleate) - Feb 26, 2008

February 27, 2008

• Tysabri (natalizumab - Feb 27, 2008

February 28, 2008

• Heparin Sodium Injection (Baxter)

February 29, 2008

• Spiriva (tiotropium bromide inhalation powder) and Foradil (formoterol fumarate inhalation powder) Capsules

March 3, 2008

• Fentanyl Transdermal System CII Patches

March 4, 2008

• Aspire36, Aspire Lite Dietary Supplements
• Tamiflu (oseltamivir phosphate) - Mar 3, 2008

March 6, 2008

• Unapproved Over The Counter Drugs Marketed for Prevention and Treatment of STDs

March 11, 2008

• Long-Acting Hydrocodone-Containing Cough Product (marketed as Tussionex Pennkinetic Extended-Release Suspension)
• Chattem Icy Hot Heat Therapy Products
• Blood Glucose Meters and Test Strips

March 12, 2008

• Erythropoiesis Stimulating Agents: Aranesp (darbepoetin alfa), Epogen (epoetin alfa), and Procrit (epoetin alfa)
• Prezista (darunavir)

March 18, 2008

• Tiotropium (marketed as Spiriva HandiHaler)
• Medtronic AneuRx Stent Graft System

March 21, 2008

• B. Braun Heparin Sodium in 5% Dextrose and 0.9% Sodium Chloride Injection Solution
• Medtronic Neuromodulation SynchroMed EL, SynchroMed II and IsoMed Implantable Infusion Pumps
• Prezista (darunavir)

March 25, 2008

• "Blue Steel" and "Hero" Dietary Supplement Products

March 27, 2008

• Ziagen (abacavir) and Videx (didanosine)
• Regranex (becaplermin) Gel
• Singulair (montelukast)

March 28, 2008

• Total Body Formula, Total Body Mega Formula

April 2, 2008

• Heparin Sodium USP Pre-Filled Syringes
• Relenza (zanamivir)

April 9, 2008

• Exubera (insulin human rDNA origin) Inhalation Powder
• Cubicin (daptomycin for injection)
• Neupro (rotigotine transdermal system)

April 10, 2008

• CellCept (mycophenolate mofetil), Myfortic (mycophenolate acid)
• Total Body Formula, Total Body Mega Formula

April 14, 2008

• Herbal Science International, Inc. Dietary Herbal Supplements

April 28, 2008

• Digitek (digoxin tablets, USP)

April 29, 2008

• Heparin Sodium Injection

May 1, 2008

• Enbrel (etanercept)
• Total Body Formula, Total Body Mega Formula

May 6, 2008

• Cardinal Alcohol-Free Mouthwash

May 9, 2008

• Heparin Sodium Injection

May 16, 2008

• Mycophenolate Mofetil (marketed as CellCept) and Mycophenolic Acid (marketed as Myfortic)

May 19, 2008

• Cardinal Alcohol-Free Mouthwash
• Solodyn (minocycline HCL) Extended Release Tablets 90 mg

May 27, 2008

• Xiadafil VIP Tablets

May 29, 2008

• Mommy's Bliss Nipple Cream

May 30, 2008

• Viril-ity Power (VIP) Tablets

June 2, 2008

• Calcilo XD Low-Calcium Vitamin D-Free Infant Formula With Iron Powder

June 4, 2008

• Tumor Necrosis Factor (TNF) Blockers (marketed as Remicade, Enbrel, Humira, and Cimzia)

June 6, 2008

• Regranex (becaplermin) Gel

June 10, 2008

• Morphine Sulfate 60 mg Extended Release Tablets

June 16, 2008

• Antipsychotics, Conventional and Atypical
• Morphine Sulfate 60 mg and 30 mg Extended Release Tablets

June 30, 2008

• 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation Product

July 1, 2008

• Myfortic (mycophenolate acid)

July 2, 2008

• Rize 2 The Occasion Capsules and Rose 4 Her Capsules
• Recombinant Human Bone Morphogenetic Protein in Cervical Spine Fusion

July 8, 2008

• Fluoroquinolone Antimicrobial Drugs

July 10, 2008

• Herceptin 440 mg Vials and BWFI Diluent

July 14, 2008

• Avastin (bevacizumab) - Jul 14, 2008

July 16, 2008

• Electronic Medical Devices
• Sodium Polystyrene Sulfonate Suspension

July 17, 2008

• Micro-bubble Contrast Agents (marketed as Definity (Perflutren Lipid Microsphere) Injectable Suspension and Optison (Perflutren Protein-Type A Microspheres for Injection)

July 24, 2008

• Abacavir (marketed as Ziagen) and Abacavir-containing Medications

July 29, 2008

• Mitoxantrone Hydrochloride (marketed as Novantrone and generics)

July 30, 2008

• Rize 2 The Occasion Capsules, Rose 4 Her Capsules

July 31, 2008

• Viapro 375mg Capsules

August 1, 2008

• Levitronix CentriMag Extracorporeal Blood Pumping System: CentriMag Primary Console (with v200 Application Software)

August 8, 2008

• Simvastatin Used With Amiodarone

August 12, 2008

• Vivitrol (naltrexone)
• Fentanyl Transdermal System CII Patches

August 14, 2008

• Boston Scientific NexStent Monorail, NexStent Carotid Stent and Monorail Delivery System

August 18, 2008

• Byetta (exenatide)

August 21, 2008

• Ezetimibe/Simvastatin (Vytorin); Simvastatin (Zocor); and Ezetimibe (Zetia)

August 25, 2008

• Tysabri (natalizumab) - Aug 25, 2008

September 1, 2008

• Pacific Consolidated brand Mobile Oxygen Storage Tank

September 4, 2008

• Tumor necrosis factor-alpha blockers (TNF blockers), Cimzia (certolizumab pegol), Enbrel (etanercept), Humira (adalimumab), and Remicade (infliximab)

September 8, 2008

• Disposable Battery Operated Lavage System (BOLS)

September 11, 2008

• LifePak CR Plus Automated External Defibrillators
• Rituxan (rituximab) - Sep 11, 2008

September 12, 2008

• Infant Formula Manufactured in China

September 16, 2008

• LifePak CR Plus Automated External Defibrillators

September 18, 2008

• Phosphocol P 32 (Chromic Phosphate P 32 Suspension)

September 22, 2008

• Infant Formula Manufactured in China Contaminated With Melamine

September 23, 2008

• Ammonul (sodium phenylacetate and sodium benzoate) Injection 10%/10%
• Tarceva (erlotinib) - September 23, 2008

September 26, 2008

• Epoetin alfa

September 30, 2008

• Statin drugs and amyotrophic lateral sclerosis (ALS)

October 2, 2008

• Medtronic Neuromodulation INDURA One-Piece Intrathecal Catheters, Sutureless Pump Connector Revision Kit, Intrathecal Catheter Pump Segment Revision Kit

October 3, 2008

• Nebion HLX-8 Magnetic Resonance Device

October 7, 2008

• Tiotropium (marketed as Spiriva HandiHaler)

October 9, 2008

• Over The Counter Cough and Cold Medications

October 16, 2008

• Dextroamphetamine Sulfate 5mg Tablets

October 17, 2008

• Raptiva (efalizumab) - Oct 17, 2008

November 6, 2008

• ReliOn Insulin Syringes for use with U-100 Insulin (Tyco Healthcare - Covidien)

November 10, 2008

• Propafenone HCl Tablets (150 mg, 225 mg, 300 mg), Isosorbide Mononitrate Extended Release Tablets (30 mg and 60 mg), Morphine Sulfate Extended Release Tablets (15 mg), Morphine Sulfate Immediate Release Tablets (15 mg and 30 mg), Dextroamphetamine Sulfate Tablets (10 mg)

November 12, 2008

• Update on Early Communication: Bisphosphonates marketed as Alendronate (Fosamax, Fosamax Plus D); Etidronate (Didronel); Ibandronate (Boniva); Pamidronate (Aredia); Risedronate (Actonel, Actonel W/Calcium); Tiludronate (Skelid); Zoledronic acid (Reclast, Zometa)
• Infants' Mylicon Gas Relief Dye Free Drops (Simethicone-Antigas)

November 17, 2008

• Benzoyl Peroxide Acne Cream 10% marked as: DG Maximum Strength Acne Medicated Gel; Kroger Acne Gel 10% Benzoyl Peroxide Acne Medication; Equate: Medicated Acne Gel

November 20, 2008

• Animas Corporation Battery Caps Used with the OneTouch Ping System, Animas 2020 Insulin Pump, Animas IR1200 Insulin Pump, and Animas IR1250 Insulin Pump

November 24, 2008

• Phenytoin (marketed as Dilantin, Phenytek and generics) and Fosphenytoin Sodium (marketed as Cerebyx and generics)

November 26, 2008

• Starcaps Dietary Supplement Capsules
• Zhen De Shou Fat Loss Capsules

December 2, 2008

• Innohep (tinzaparin sodium injection)
• Erythropoiesis Stimulating Agents (ESAs) - Epoetin alfa (marketed as Procrit, Epogen), Darbepoetin alfa (marketed as Aranesp)

December 8, 2008

• Terumo Cardiovascular Systems Tenderflow Pediatric Arterial Cannulae

December 9, 2008

• 20 mEq Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP

December 11, 2008

• Oral Sodium Phosphate (OSP) Products for Bowel Cleansing (marketed as Visicol and OsmoPrep, and oral sodium phosphate products available without a prescription)
• Healon D Ophthalmic Viscosurgical Device

December 24, 2008

• Hydromorphone HCl 2 mg Tablets

December 31, 2008

• Innohep (tinzaparin sodium injection)