Safety

2011 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.

MedWatch "What's New" Archive, Jan 01 - Dec 31, 2011

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	02/23/2012
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	11/04/2011
Benzocaine Topical Products: Sprays, Gels and Liquids - Risk of Methemoglobinemia	04/07/2011
Birth Control Pills Containing Drospirenone: Possible Increased Risk of Blood Clots	10/27/2011
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	01/12/2012
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
Gilenya (fingolimod): Drug Safety Communication - Safety Review of a Reported Death After the First Dose	05/14/2012
H & P Industries Povidone Iodine Swabsticks, Prep Solutions, Scrub Solutions, and Prep Gel: Recall - Inadequate Microbial Testing	09/25/2012
H & P Industries Povidone Iodine Prep Pads: Recall - Potential Microbial Contamination	02/08/2012
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
Liquid Acetaminophen marketed for infants: Drug Safety Communication - Potential for Dosing Errors	12/22/2011
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	10/21/2011
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	12/19/2011
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
Nostrilla Nasal Decongestant: Recall - Bacterial Contamination	10/21/2011
Nulojix (belatacept): Risk Evaluation and Mitigation Strategy (REMS)	07/07/2011
Ondansetron (Zofran) IV: Drug Safety Communication - QT prolongation	06/29/2012
Oral Osteoporosis Drugs (bisphosphonates): Drug Safety Communication - Potential Increased Risk of Esophageal Cancer	07/21/2011
Pradaxa (dabigatran etexilate mesylate): Drug Safety Communication - Safety Review of Post-Market Reports of Serious Bleeding Events	12/07/2011
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
Qualitest Pharmaceuticals Oral Contraceptives: Recall - Packaging Error	09/16/2011
Reclast (zoledronic acid): Drug Safety Communication - New Contraindication and Updated Warning on Kidney Impairment	09/01/2011
Revlimid (lenalidomide): Ongoing Safety Review - Increased Risk of Developing New Malignancies	05/07/2012
Risperdal (risperidone) and Risperidone: Recall - Uncharacteristic Odor	06/20/2011
Risperidone (Risperdal) and Ropinirole (Requip): Medication Errors - Name Confusion	06/13/2011
Saphris (asenapine maleate): Drug Safety Communication: Serious Allergic Reactions	09/01/2011
Selective Serotonin Reuptake Inhibitor (SSRI) Antidepressants: Drug Safety Communication - Use During Pregnancy and Potential Risk of Persistent Pulmonary Hypertension of the Newborn	12/14/2011
Sprycel (dasatinib): Drug Safety Communication - Risk of Pulmonary Arterial Hypertension	10/11/2011
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
Trilipix (fenofibric acid): Drug Safety Communication - Label Change	11/09/2011
Tumor Necrosis Factor-alpha (TNFα) Blockers: Label Change - Boxed Warning Updated for Risk of Infection from Legionella and Listeria	09/07/2011
Tumor Necrosis Factor (TNF) blockers, Azathioprine and/or Mercaptopurine: Update on Reports of Hepatosplenic T-Cell Lymphoma in Adolescents and Young Adults	11/04/2011
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
Xigris [drotrecogin alfa (activated)]: Market Withdrawal - Failure to Show Survival Benefit	10/25/2011
Zocor (simvastatin): Label Change - New Restrictions, Contraindications, and Dose Limitations	12/15/2011
Zofran (ondansetron): Drug Safety Communication - Risk of Abnormal Heart Rhythms	09/15/2011
Zyvox (linezolid): Drug Safety Communication - Serious CNS Reactions Possible When Given to Patients Taking Certain Psychiatric Medications	10/21/2011

Medical Devices

Product Name	Date Issued/Updated
Abbott Glucose Test Strips: Recall - False Low Blood Glucose Results	02/15/2011
AngioScore Inc., AngioSculpt Percutaneous Transluminal Angioplasty (PTA) Scoring Balloon Catheter OTW 0.018" Platform - Class I Recall	01/05/2011
Arrow International, Inc. Arrow NextStep Antegrade Chronic Hemodialysis Catheter: Class I Recall	08/03/2011
Arstasis One Access System: Class I Recall - Components May Fracture and/or Separate	02/09/2011
Axxent FlexiShield Mini by iCAD (formerly Xoft Inc.): Recall- Product May Shed Particles of Tungsten	04/13/2011
Beckman Coulter, Inc., Synchron LX Clinical Systems Ion Selective Electrolyte (ISE) Flow Cell: Class I Recall - Incorrect Electrolyte Results	05/23/2011
Boston Scientific Devices Stolen – Risk of Infection	05/04/2011
Boston Scientific iCross and Atlantis SR Pro 2 Coronary Imaging Catheters: Recall – Catheter Tip Can Break Inside of the Patient	06/14/2011
Boston Scientific Innova Self-Expanding Stent System: Recall - Failure to Deploy	06/17/2011
B. Braun Outlook 400ES Safety Infusion System, Model Number 621-400ES: Class I Recall - Hardware May Become Unresponsive	02/01/2011
Breast Implants: FDA Review Indicates Possible Association With A Rare Cancer	01/26/2011
CareFusion AVEA Ventilator: Recall - Failure May Lead to Lack of Ventilation	12/23/2011
CareFusion EnVe Ventilators: Class I Recall - Potential for Interruption of Patient Ventilation	11/04/2011
Cook Inc., Single, Double, Triple and Five-Lumen Central Venous Catheter Trays AND Single and Double Lumen PICC Peripheral Inserted Central Venous Catheter Trays: Class I Recall - Leaks in Plunger Luer Detected	03/03/2011
CooperVision AVAIRA Toric and Sphere Soft Contact Lenses: Class 1 Recall - Unintended Residue on Lenses	12/09/2011
Davol XenMatrix Surgical Graft: Class I Recall - Elevated Endotoxin Levels	03/04/2011
Defibtech Lifeline and ReviveR Automated External Defibrillators (AEDs): Recall - Software Defect May Cancel Shock	05/11/2011
Fresenius Medical Care North America, CombiSet True Flow Series Hemodialysis Blood Tubing Set with Priming Set and Transducer Protectors for Use with the Blood Volume Monitor: Class I Recall - Potential for Kinking of Arterial Line	01/21/2011
GE Healthcare Vital Signs Hygroscopic Condenser Humidifier Passive Humidification Device (HCH): Class I Recall	08/03/2011
GEM Premier 4000 PAK Cartridges for Use on the GEM Premier 4000 System: Class I Recall - Innaccurate Results	08/01/2011
Gen-Probe Inc., AccuProbe Group B Streptococcus Culture Identification Test, AccuProbe Mycobacterium Tuberculosis Complex Culture Identification Test and, AccuProbe Mycobacterium Avium Complex Culture Identification Test: Class I Recall	03/17/2011
Heartstring II Proximal Seal System (HS-1045) by Maquet Cardiovascular, LLC: Recall - Insufficient Adhesive	04/01/2011
Maquet Datascope Corp. Intra-Aortic Balloon Pumps: Recall – Shuts Off Without Warning	06/14/2011
Medtronic Model 8637 SynchroMed II Implantable Infusion Pump: Class I Recall - Potential for Reduced Battery Performance	09/12/2011
Medtronic SynchroMed II and SynchroMed EL Implantable Infusion Pump and Refill Kits: Class 1 Recall	02/16/2011
Merit Prelude Short Sheath Catheter Introducer: Class I Recall - Tip May Detach During Use	02/04/2011
Mikro-Tip Angiographic Catheter, Model SPC-454D and SPC-454F by Millar Instruments Inc.: Class 1 Recall	04/01/2011
Mizuho OSI Modular Table Systems: Class I Recall - Reports of Patient Injury	11/09/2011
Negative Pressure Wound Therapy (NPWT) systems - Preliminary Public Health Notification	02/28/2011
Oridion Medical and Philips Healthcare Microstream CO2 Filterline (FilterLine H Set Infant/Neonate, VitaLine H Set Infant/Neonate: Recall - Plastic Strands on the Adapter May Become Dislodged, Inhaled by Patient	06/07/2011
Penumbra Coil 400 by Penumbra Inc.: Class 1 Recall - Premature Detachment of the Coil	04/13/2011
Roche ACCU-CHEK FlexLink Plus Infusion Set: Class I Recall - Potential for Under-Delivery of Insulin	03/29/2011
ShoulderFlex Massager: Warning - Risk of Strangulation	12/21/2011
ShoulderFlex Massager by King International: Safety Communication - Risk of Strangulation	11/17/2011
Silencer S2200 Centrifuge by Global Focus Marketing & Distribution, Ltd.: Class I Recall - Biohazardous Materials May be Released	07/27/2011
St. Jude Medical, Riata and Riata ST Silicone Endocardial Defibrillation Leads: Class 1 Recall - Failures with Lead Insulation	12/21/2011
Terumo Coronary Ostia Cannula 10, 12, 14 Fr: Recall – Fragments of Adhesive and Plastic in the Cannula Tip May Embolize	06/14/2011
Thermographic Imaging Systems for Breast Cancer Screening: FDA Safety Communication	06/02/2011
Transvaginal Placement of Surgical Mesh	07/13/2011
Triad Sterile Lubricating Jelly: Recall - Product May Not Be Sterile	02/16/2011
Weck Hem-o-Lok Ligating Clips: Contraindicated for Ligation of Renal Artery During Laparoscopic Living-Donor Nephrectomy	05/06/2011

Special Nutritional and Cosmetic Products

Product Name	Date Issued/Updated
Eclectic Institute Dietary Supplements: Recall - Possible Salmonella Contamination	12/22/2011
SimplyThick: Public Health Notification - Risk of Life-Threatening Bowel Condition	09/18/2012
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

Products With Undeclared Drug Ingredients

Product Name	Date Issued/Updated
Best Enhancer: Recall – Undeclared Drug Ingredient	04/05/2011
Black Ant: Undeclared Drug Ingredient	03/16/2011
Celerite Slimming Capsules: Undeclared Drug Ingredient	01/13/2011
Celerite Slimming Tea: Recall - Undeclared Drug Ingredient	03/28/2011
ExtenZe Tablets: Recall	05/16/2011
Nite Rider Maximum Sexual Enhancer For Men and STUD Capsules for Men: Recall - Undeclared Drug Ingredient	01/27/2011
Regenerect: Recall - Undeclared Drug Ingredient	02/27/2012
Slim Forte Slimming Capsules, Slim Forte Slimming Coffee, and Botanical Slimming Soft Gel: Public Notification - Undeclared Drug Ingredient	07/27/2011
Slim Forte Slimming Capsule and Slim Forte Double Power Slimming Capsules: Public Notification - Undeclared Drug Ingredient	07/08/2011
Slim Xtreme Herbal Slimming Capsule: Undeclared Drug Ingredient	05/26/2011
Svelte 30: Recall - Undeclared Drug Ingredient	02/25/2011
Uprizing 2.0: Recall - Undeclared Drug Ingredient: Synthetic Steroid	10/06/2011
U-Prosta: Undeclared Drug Ingredient	03/24/2011
Via Xtreme Ultimate Sexual Enhancer Dietary Supplement For Men: Recall - Undeclared Drug Ingredient	06/07/2011
Virility Max: Recall - Undeclared Drug Ingredient	11/14/2011
X-Hero and Male Enhancer: Recall - Undeclared Drug Ingredient	03/29/2011

Safety

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2011 Safety Alerts for Human Medical Products

Drugs and Therapeutic Biological Products

Medical Devices

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Products With Undeclared Drug Ingredients

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