FDA Alerts Archive for 2010

January 11, 2010

• Rapamune (sirolimus): Drug Monitoring Recommendations

January 15, 2010

• McNeil Consumer Healthcare Over-The-Counter Products: Recall
• Tylenol Arthritis Pain Caplet, 100 count bottles: Recall of all lots
• MuscleMaster.com Products Sold on Internet as Dietary Supplements: Recall

January 18, 2010

• Alli 60 mg capsules (120 count refill kit): Counterfeit Product

January 21, 2010

• Meridia (sibutramine hydrochloride): Follow-Up to an Early Communication about an Ongoing Safety Review

January 22, 2010

• Nipro GlucoPro Insulin Syringes: Recall

January 23, 2010

• Alli 60 mg capsules (120 count refill kit): Counterfeit Product

January 26, 2010

• Velcade (bortezomib): Starting Dose Adjustments for Patients with Hepatic Impairment

January 29, 2010

• Videx/Videx EC (didanosine): Labeling Revision - Risk of Non-Cirrhotic Portal Hypertension
• Zyprexa (olanzapine): Use in Adolescents

February 5, 2010

• Tysabri (Natalizumab): Update of Healthcare Professional Information

February 16, 2010

• Erythropoiesis-Stimulating Agents (ESAs): Procrit, Epogen and Aranesp: Drug Safety Communication

February 17, 2010

• Maalox Total Relief and Maalox Liquid Products: Medication Use Errors

February 18, 2010

• Exjade (deferasirox): Boxed Warning
• Long-Acting Beta-Agonists (LABAs): New Safe Use Requirements

February 22, 2010

• Avandia (rosiglitazone): Ongoing Review of Cardiovascular Safety

February 23, 2010

• Invirase (saquinavir): Ongoing safety review of clinical trial data

March 10, 2010

• WinRho SDF (Rho(D) Immune Globulin Intravenous (Human): Risk of Intravascular Hemolysis

March 11, 2010

• Oral Bisphosphonates: Ongoing Safety Review of Atypical Subtrochanteric Femur Fractures

March 12, 2010

• Plavix (clopidogrel): Reduced effectiveness in patients who are poor metabolizers of the drug

March 17, 2010

• Cleviprex (clevidipine butyrate): Recall

March 19, 2010

• Zocor (simvastatin): increased risk of muscle injury with high doses

March 22, 2010

• Rotarix Vaccine: Update to Clinicians and Public Health Professionals

March 30, 2010

• MasXtreme Capsules (Natural Wellness) - product contains undeclared drug ingredient

March 31, 2010

• Stalevo (entacapone/carbidopa/levodopa): Ongoing Safety Review

April 6, 2010

• Stud Capsule For Men: Product contains Undeclared Drug Ingredient

April 7, 2010

• Camolyn eye drops, Fisiolin nasal drops: Voluntary recall due to non-sterility
• Heparin: Change in Reference Standard

April 14, 2010

• Atlas Operations, Inc.: Recall of Sexual Enhancement Products

April 21, 2010

• Propylthiouracil

April 30, 2010

• McNeil Consumer Healthcare Over-the-Counter Infants' and Children's Products: Recall

May 3, 2010

• GnRH Agonists: Safety Review of Drug Class Used to Treat Prostate Cancer
• Vita Breath Dietary Supplement

May 4, 2010

• Vivitrol (naltrexone for extended-release injectable suspension): Medication Guide Required for Patients
• Baxter Colleague Infusion Pumps: FDA Ordering Recall

May 12, 2010

• Promacta (eltrombopag): Portal Venous System Thromboses in Study of Patients With Chronic Liver Disease
• Benadryl Extra Strength Itch Stopping Gel: Packaging Changes to Reduce Use Errors

May 16, 2010

• Rotarix Vaccine: Update to Clinicians and Public Health Professionals

May 17, 2010

• Metronidazole injection 500 mg / 100 ml: Voluntary recall due to non-sterility

May 25, 2010

• Proton Pump Inhibitors (PPI): Class Labeling Change
• Ultram (tramadol hydrochloride), Ultracet (tramadol hydrochloride/acetaminophen): Label Change

May 26, 2010

• Hylenex recombinant (hyaluronidase human injection): Recall
• Orlistat (marketed as Alli and Xenical): Labeling Change

May 28, 2010

• Arrow Brand Medicated Oil and Embrocation: Consumer Warning, Product Considered Toxic

May 29, 2010

• Intravenous Medications Manufactured by Claris: Recall due to contamination of products
• PediaCare Children's Products [Blacksmith Brand]: Recall of four products

June 3, 2010

• Long-Acting Beta-Agonists (LABAs): New Safe Use Requirements

June 4, 2010

• GammaGard Liquid, Immune Globulin Intravenous (Human)

June 10, 2010

• Hospira Brand Liposyn and Propofol: Recall

June 11, 2010

• Benicar (olmesartan): Ongoing Safety Review

June 15, 2010

• Vitamin D Supplement Products: Medication Use Error

June 17, 2010

• Tamiflu: Counterfeit Product Sold on Internet
• McNeil Consumer Healthcare Over-The-Counter Products: Recall

June 21, 2010

• Mylotarg (gemtuzumab ozogamicin): Market Withdrawal
• Magic Power Coffee: Undeclared Drug Ingredient

July 8, 2010

• Que She Herbal Supplement: Undeclared Drug Ingredients
• Qualaquin (quinine sulfate): New Risk Evaluation and Mitigation Strategy - Risk of serious hematological reactions
• McNeil Consumer Healthcare Over-The-Counter Products: Recall

July 13, 2010

• Arava (leflunomide): Boxed Warning - Risk of Severe Liver Injury

July 14, 2010

• Coumadin 1 mg Tablet Blister Packs: Recall

July 15, 2010

• Angiotensin Receptor Blockers (ARBs): Ongoing Safety Review for Cancer Risk

July 16, 2010

• Advair Diskus (fluticasone propionate and salmeterol inhalation powder): Stolen Product Warning

July 19, 2010

• Slim- 30 Herb Supplement: Undeclared Drug Ingredient

July 20, 2010

• Vialipro Dietary Supplement: Recall-Undeclared Drug Ingredient

July 22, 2010

• Joyful Slim Herb Supplement : Recall - Undeclared Drug Ingredient

July 29, 2010

• Evamist (estradiol transdermal spray): Drug Safety Communication - Unintended Exposure of Children and Pets to Topical Estrogen
• Cubicin (daptomycin): Drug Safety Communication - Risk of Eosinophilic Pneumonia

July 30, 2010

• Afluria (CSL Ltd.) Influenza Virus Vaccine: Label Change - Risk of Fever and Febrile Seizure
• Miracle Mineral Solution (MMS): Product as consumed produces a potent bleach
• Nutraloid Labs ejaculoid XXTREME and stimuloid II: Undeclared Drug Ingredient

August 2, 2010

• Nimodipine Oral Capsules: Medication Errors - IV Administration May Result in Death, Serious Harms
• NeoProfen (ibuprofen lysine) Injection: Recall and Shortage - Risk of Particulate Matter

August 4, 2010

• Qualaquin (quinine sulfate): New Risk Evaluation and Mitigation Strategy - Risk of serious hematological reactions

August 9, 2010

• Solo Slim, Solo Slim Extra Strength: Recall - Undeclared Drug Ingredient
• Revivexxx Extra Strength: Recall - Undeclared Drug Ingredient

August 11, 2010

• Novacare LLC Products: Recall - Undeclared Drug Ingredient

August 12, 2010

• Lamictal (lamotrigine): Label Change - Risk of Aseptic Meningitis

August 13, 2010

• Prolatis': Undeclared Drug Ingredient

August 16, 2010

• Midodrine hydrochloride: FDA Proposes Withdrawal of Low Blood Pressure Drug

August 20, 2010

• Stalevo(carbidopa/levodopa and entacapone): Ongoing Safety Review: Possible increased cardiovascular risk

August 24, 2010

• Mr. Magic Male Enhancer: Undeclared Drug Ingredient

August 25, 2010

• TimeOut Capsules: Undeclared Drug Ingredient
• MasXtreme Capsules (Natural Wellness) - product contains undeclared drug ingredient
• Octagam (Immune Globulin Intravenous (human)) 5% Liquid Preparation: Market Withdrawal - Risk of Thromboembolic Events

September 1, 2010

• Tygacil (tigecycline): Label Change - Increased Mortality Risk

September 9, 2010

• Gadolinium-based Contrast Agents: Class Labeling Change - Risk of Nephrogenic Systemic Fibrosis

September 15, 2010

• Valcyte (valganciclovir hydrochloride) Label Change: Possible overdose in pediatric patients

September 17, 2010

• Actos (pioglitazone): Ongoing Safety Review - Potential Increased Risk of Bladder Cancer

September 20, 2010

• Aromatase Inhibitors in Products Marketed as Dietary Supplements: Recall

September 23, 2010

• Avandia (rosiglitazone): REMS - Risk of Cardiovascular Events
• Similac Powder Infant Formulas: Recall

September 24, 2010

• Similac Powder Infant Formulas: Recall
• Epogen and Procrit (epoetin alfa): Recall - Particulate Matter in Vials

September 29, 2010

• Infant sleep positioners: Consumer Warning - Risk of Suffocation

October 8, 2010

• Slimming Beauty Bitter Orange Slimming Capsules: Undeclared Drug Ingredient
• Meridia (sibutramine): Market Withdrawal Due to Risk of Serious Cardiovascular Events
• Aromatase Inhibitors in Products Marketed as Dietary Supplements: Recall

October 10, 2010

• Lipitor (atorvastatin) 40 mg: Recall specific bottles

October 13, 2010

• Bisphosphonates (Osteoporosis Drugs): Label Change - Atypical Fractures Update

October 14, 2010

• Chelation Products: Unapproved Over-the-Counter Drugs - Consumer Warning

October 15, 2010

• Excelsior Medical 5 ml Fill in 6 cc Prefilled Saline Flush Syringes: Recall - Potential Loss of Sterility

October 19, 2010

• Tylenol 8 Hour Caplets 50 Count: Recall

October 20, 2010

• GnRH Agonists: Label Change - Increased Risk of Diabetes and Cardiovascular Disease (Update)

October 21, 2010

• Invirase (saquinavir): Label Change - Risk of Abnormal Heart Rhythm

October 22, 2010

• Fentanyl Transdermal System: Recall - Potential for Active Ingredient to Release Faster Than Specified

October 24, 2010

• Hyland's Teething Tablets: Recall - Risk of Harm to Children

October 29, 2010

• Heparin Sodium (B. Braun): Recall - Trace Contaminant
• Methotrexate Injection, 50mg/2mL and 250mg/10mL Vials: Recall - Presence of Glass Particulates

November 5, 2010

• Duro Extend Capsules for Men: Recall - Undeclared Drug Ingredient
• Fentanyl Transdermal System: Recall - Potential for Active Ingredient to Release Faster Than Specified

November 19, 2010

• Propoxyphene: Withdrawal - Risk of Cardiac Toxicity
• Vigor-25: Undeclared Drug Ingredient-Sold as natural dietary supplement

December 6, 2010

• Duro Extend Capsules for Men: Recall - Undeclared Drug Ingredient

December 13, 2010

• Man Up Now Capsules: Consumer Warning - Undeclared Drug Ingredient
• Reese Pharmaceutical Company OTC Products: Recall - Mislabeled Guaifenesin Tablets

December 14, 2010

• Tessalon (benzonatate): Drug Safety Communication - Potential for Accidental Ingestion by Children
• Rolaids Extra Strength Softchews, Rolaids Extra Strength plus Gas Softchews, Rolaids Multi-Symptom plus Anti-Gas Softchews: Recall - Foreign Materials in Products

December 16, 2010

• Avastin (bevacizumab): Process for Removal of Breast Cancer Indication Begun

December 17, 2010

• Anzemet (dolasetron mesylate): Drug Safety Communication - Reports of Abnormal Heart Rhythms

December 22, 2010

• Abbott Glucose Test Strips: Recall - False Low Blood Glucose Results
• Recombinant Human Growth Hormone (somatropin): Ongoing Safety Review - Possible Increased Risk of Death

December 23, 2010

• Lipitor (atorvastatin) 40 mg: Recall Specific Bottles
• RockHard Weekend, Pandora: Recall - Undeclared Drug Ingredient
• Fruta Planta: Public Notification - Undeclared Drug Ingredient

December 24, 2010

• Dexamethasone Sodium Phosphate Injection, 4 mg/mL, 30 mL Multiple Dose Vial: Recall due to Particulates in Product

December 29, 2010

• Sodium Bicarbonate Injection, USP, 7.5% and 8.4%, 50 mL Single Dose Vials - Recall Due to Particulates in Some Vials