2011 Safety Alerts for Human Medical Products
Drugs and Therapeutic Biological Products
Product Name Date Issued/Updated
5-alpha reductase inhibitors (5-ARIs): Label Change - Increased Risk of Prostate Cancer 06/09/2011
Abacavir - Ongoing Safety Review: Possible Increased Risk of Heart Attack 03/01/2011
Acetadote (acetylcysteine) Injection: Recall - Particulate Matter Found in a Small Number of Vials 01/01/2011
Acetaminophen Prescription Products Limited to 325 mg Per Dosage Unit: Drug Safety Communication 01/13/2011
Aidapak Services Repackaged Pharmaceuticals: Recall - Potential Cross Contamination with Beta Lactam Products 06/03/2011
Albuterol Sulfate Inhalation Solution 0.083%, 3 mL Unit Dose Vials: Recall - Mislabeled Unit Dose Vials 01/03/2011
American Regent Injectable Products: Recall - Visible Particulates in Products 07/20/2011
Angiotensin Receptor Blockers (ARBs): Drug Safety Communication - Drug Safety Review Completed 06/02/2011
Antipsychotic drugs: Class Labeling Change - Treatment During Pregnancy and Potential Risk to Newborns 02/22/2011
Avandia (rosiglitazone): REMS - Risk of Cardiovascular Events 05/18/2011
Benzocaine Topical Products: Sprays, Gels and Liquids - Risk of Methemoglobinemia 04/07/2011
Birth Control Pills Containing Drospirenone: Possible Increased Risk of Blood Clots 05/31/2011
Butalbital, Acetaminophen, and Caffeine Tablets (USP 50mg, 325mg, 40mg) and Hydrocodone Bitartrate and Acetaminophen Tablets (USP 7.5mg, 500mg): Recall - Bottle Mislabeled 06/27/2011
CardioGen-82 PET Scan: Drug Safety Communication - Increased Radiation Exposure 07/26/2011
Celexa (citalopram hydrobromide): Drug Safety Communication - Abnormal Heart Rhythms Associated With High Doses 08/24/2011
Chantix (varenicline): Label Change - Risk of Certain Cardiovascular Adverse Events 07/22/2011
Citalopram And Finasteride by Greenstone: Recall - Possible Mislabeling 03/28/2011
Coumadin (warfarin sodium) Crystalline 5 mg Tablets: Recall - Tablets May Have Higher than Expected Potency 05/03/2011
Diflucan (fluconazole): Drug Safety Communication – Long-term, High-dose Use During Pregnancy May Be Associated With Birth Defects 08/03/2011
Endocet (Oxycodone / Acetaminophen) Tablets, ( 10mg, 325mg ) : Recall - Some Bottles Contain Different Strength Tablets 06/27/2011
Erythropoiesis-Stimulating Agents (ESAs) In Chronic Kidney Disease: Drug Safety Communication - Modified Dosing Recommendations 06/24/2011
H & P Industries Povidone Iodine Prep Pads: Recall - Potential Microbial Contamination 03/18/2011
Hydrocodone Bitartrate And Acetaminophen Tablets, Phenobarbital Tablets by Qualitest: Recall - Incorrect Package Labeling 02/07/2011
Indomethacin for Injection: Recall of One Lot - Particulate Matter 06/15/2011
Irinotecan Hydrochloride Injection: Recall - Fungal Microbial Contaminant 03/28/2011
Kaletra (lopinavir/ritonavir): Label Change - Serious Health Problems in Premature Babies 03/08/2011
Lansoprazole Delayed-Release Orally Disintegrating Tablets by Teva Pharmaceuticals: Letter to Healthcare Professionals - Clogged, Blocked Oral Syringes and Feeding Tubes 04/15/2011
Long-Acting Beta-Agonists (LABAs): New Safe Use Requirements 04/15/2011
Meds IV Pharmacy, IV Compounded Products Recall: Outbreak of Serratia Marcescens Bacteremia in Alabama Hospitals 03/30/2011
Methylene Blue: Drug Safety Communication - Serious CNS Reactions Possible When Given to Patients Taking Certain Psychiatric Medications 07/26/2011
Metronidazole Tablets, 250mg: Recall - Underweight Tablets 01/06/2011
Morphine Sulfate Oral Solution 100 mg per 5 mL (20 mg/mL): Medication Use Error - Reports of Accidental Overdose 01/10/2011
Multaq (dronedarone): Drug Safety Communication - Increased Risk of Death or Serious Cardiovascular Events 07/21/2011
Multaq (dronedarone) - Drug Safety Communication: Risk of Severe Liver Injury 01/14/2011
Nature Relief Instant Wart and Mole Remover: Recall - Risk of Severe Skin Burns 06/27/2011
Needleless Pre-filled Glass Syringes: Stakeholder Advisory - Compatibility Problems with Needleless Intravenous Access Systems 05/06/2011
Nulojix (belatacept): Risk Evaluation and Mitigation Strategy (REMS) 07/07/2011
Oral Osteoporosis Drugs (bisphosphonates): Drug Safety Communication - Potential Increased Risk of Esophageal Cancer 07/21/2011
Pradaxa (dabigatran etexilate mesylate) Capsules: Special Storage and Handling Requirements 03/30/2011
Proton Pump Inhibitor drugs (PPIs): Drug Safety Communication - Low Magnesium Levels Can Be Associated With Long-Term Use 03/02/2011
Revlimid (lenalidomide): Ongoing Safety Review - Increased Risk of Developing New Malignancies 04/08/2011
Risperdal (risperidone) and Risperidone: Recall - Uncharacteristic Odor 06/20/2011
Risperidone (Risperdal) and Ropinirole (Requip): Medication Errors - Name Confusion 06/13/2011
Tamiflu (oseltamivir phosphate) for Oral Suspension: Label Change-New Concentration (6 mg/mL) 07/11/2011
Terbutaline: Label Change - Warnings Against Use for Treatment of Preterm Labor 02/17/2011
Topamax (topiramate): Recall - Musty Odor 04/15/2011
Topamax (topiramate): Label Change - Risk For Development of Cleft Lip and/or Cleft Palate in Newborns 03/04/2011
Triad Alcohol Prep Pads, Alcohol Swabs, and Alcohol Swabsticks: Recall Due to Potential Microbial Contamination 06/08/2011
Tumor Necrosis Factor (TNF) blockers, Azathioprine and/or Mercaptopurine: Update on Reports of Hepatosplenic T-Cell Lymphoma in Adolescents and Young Adults 04/14/2011
Tylenol Extra Strength Caplets, 225 count bottles: Recall - Uncharacteristic Odor 06/29/2011
Tysabri (natalizumab): Update of Healthcare Professional Information 04/22/2011
Unapproved Cough, Cold, Allergy Products: FDA Prompts Removal From Market 03/02/2011
Warfarin Sodium Tablets (Jantoven), 3mg: Recall - Mislabeled Bottles Containing Higher Dosage 02/21/2011
Yervoy (ipilimumab): Risk Evaluation and Mitigation Strategy (REMS) - Severe Immune-Mediated Adverse Reactions 04/06/2011
Valproate Products: Drug Safety Communication - Risk of Impaired Cognitive Development in Children Exposed In Utero (During Pregnancy) 06/30/2011
Vasopressin Injection USP, Multiple Dose Vials: Recall - Sub-Potency 08/04/2011
Victoza (liraglutide [rDNA origin]) Injection: REMS - Risk of Thyroid C-cell Tumors, Acute Pancreatitis 06/13/2011
Zocor (simvastatin): Label Change - New Restrictions, Contraindications, and Dose Limitations 06/08/2011
Zyvox (linezolid): Drug Safety Communication - Serious CNS Reactions Possible When Given to Patients Taking Certain Psychiatric Medications 07/26/2011
Special Nutritional and Cosmetic Products
Product Name Date Issued/Updated
SimplyThick: Public Health Notification - Risk of Life-Threatening Bowel Condition 06/05/2011
Multi-Mex Distributor Inc. Dietary Supplements: Recall - Product Packaging Mimics OTC Antibiotics 05/10/2011
Pentrexyl Forte Natural: Recall - Misleading Packaging 05/23/2011
Soladek Vitamin Solution: Unapproved Product May Contain Dangerously High Levels of Vitamins A and D 03/29/2011
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