Safety

2015 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, 2015

Drugs and Therapeutic Biological Products

Product NameDate Issued/Updated
0.9 Percent Sodium Chloride Injection, USP (AUTO-C) by Baxter International: Recall - Potential For Leaking Containers, Particulate Matter and Missing Port 07/31/2015
0.9 Percent Sodium Chloride Injection, USP, 50mL and 100mL by Baxter: Recall - Particulate Matter 07/20/2015
0.9 Percent Sodium Chloride Injection, USP, 250 mL by Hospira : Recall - Particulate Matter 01/23/2015
0.9 Percent Sodium Chloride Injection, USP, 250 mL VisIV Container by Hospira: Recall - Particulate Matter 03/06/2015
Acetaminophen Tablets by Medline Industries: Recall - Mislabeling with Incorrect Strength 10/15/2015
Adrucil (fluorouracil injection, USP) 5 g/100 mL (50 mg/mL) by Teva Parenteral Medicines: Recall - Particulate Matter 07/27/2015
Adrucil (fluorouracil Injection, USP) 5 g/100 mL (50 mg/mL): Recall - Particulate Matter 05/05/2015
Atracurium Besylate Injection by Sagent Pharmaceuticals: Recall - Potential Impact on Product Sterility 02/24/2015
Auvi-Q (epinephrine injection, USP): Recall - Potential Inaccurate Dosage Delivery 10/29/2015
Avycaz (ceftazidime and avibactam): Drug Safety Communication - Dose Confusion and Medication Errors 09/22/2015
Baclofen Active Pharmaceutical Ingredient from Taizhou Xinyou Pharmaceutical and Chemical: FDA Statement - FDA Warns of Potential Contamination 12/09/2015
Brintellix (vortioxetine) and Brilinta (ticagrelor): Drug Safety Communication - Name Confusion 07/30/2015
Bupivacaine HCl Injection by Hospira: Recall - Iron Oxide Particulate In Glass Vials 04/24/2015
Calcium Chloride Intravenous Infusion 10% w/v 10mL Prefilled Syringe by Mylan: Market Withdrawal - Difficulties in Administration 07/14/2015
Chantix (varenicline): Drug Safety Communication - FDA Updates Label to Include Potential Alcohol Interaction 03/09/2015
Clozapine: Drug Safety Communication - FDA Modifies Monitoring for Neutropenia; Approves New Shared REMS Program 11/19/2015
Codeine Cough-and-Cold Medicines in Children: Drug Safety Communication - FDA Evaluating Potential Risk of Serious Side Effects 07/01/2015
Colistimethate for Injection USP, 150 mg and Rifampin for Injection USP, 600 mg/vial by Heritage Pharmaceuticals: Recall - Lack of Sterility Assurance 02/25/2015
Compounded Multivitamins by Glades Drugs: Voluntary Recall - High Amounts of Vitamin D3 (Cholecalciferol) 11/25/2015
Compounded or Repackaged Drugs Stored in Becton-Dickinson Syringes: FDA Expands Warning 09/08/2015
Compounded or Repackaged Drugs Stored in Becton-Dickinson (BD) 3 mL and 5 mL Syringes: FDA Alert - Do Not Use Unless There Is No Suitable Alternative 08/18/2015
Daytrana Patch (methylphenidate transdermal system): Drug Safety Communication - Permanent Skin Color Changes 06/24/2015
Downing Labs, LLC Sterile Compounded Products: Recall - Lack of Sterility Assurance 10/21/2015
DPP-4 Inhibitors for Type 2 Diabetes: Drug Safety Communication - May Cause Severe Joint Pain 08/28/2015
Drug Products Intended to be Sterile by Chen Shwezin Inc., dba Park Compounding Pharmacy: FDA Statement - Lack of Sterility Assurance 10/03/2015
Entacapone: Drug Safety Communication - FDA Review Found No Increased Cardiovascular Risks 10/26/2015
Feraheme (ferumoxytol): Drug Safety Communication – Warnings Strengthened and Prescribing Instructions Changed 03/31/2015
FLOW-i Anesthesia Systems by Maquet: Class I Recall - Dislodged Patient Cassette May Stop Patient Ventilation 07/01/2015
Flurbiprofen-Containing Topical Pain Medications: FDA Alert - Illnesses and Deaths in Pets Exposed to Prescription Topical Pain Medication 04/17/2015
Gadolinium-based Contrast Agents for Magnetic Resonance Imaging (MRI): Drug Safety Communication - FDA Evaluating the Risk of Brain Deposits With Repeated Use 07/27/2015
Gilenya (fingolimod): Drug Safety Communication - FDA Warns About Cases of Rare Brain Infection 08/04/2015
Hepatitis C Treatments Containing Sofosbuvir in Combination With Another Direct Acting Antiviral Drug: Drug Safety Communication - Serious Slowing of Heart Rate When Used With Antiarrhythmic Drug Amiodarone 03/24/2015
Hydrochlorothiazide Tablets by Unichem Pharmaceuticals (USA), Inc: Recall - Potential Presence of Foreign Tablets Contamination 07/31/2015
Injectable Products by Mylan: Recall - Presence of Particulate Matter 06/08/2015
Intravenous (IV) Solutions (Select Lots) by Baxter: Recall - Potential Presence of Particulate Matter 04/10/2015
Invokana and Invokamet (canagliflozin): Drug Safety Communication - New Information on Bone Fracture Risk and Decreased Bone Mineral Density 09/10/2015
Iodine-containing Contrast Agents for Medical Imaging: Drug Safety Communication - Rare Cases of Underactive Thyroid in Infants 11/17/2015
Kayexalate (sodium polystyrene sulfonate): Drug Safety Communication - FDA Requires Drug Interaction Studies 10/22/2015
Ketorolac Tromethamine Injection by Hospira: Recall - Particulate in Glass Vials 02/11/2015
Lactated Ringer's Irrigation, 3000mL by Hospira: Recall - Mold Contamination 03/12/2015
Magnesium Sulfate in 5 Percent Dextrose Injection by Hospira: Recall - Incorrect Barcode Labeling 03/06/2015
Medistat RX Sterile Drug Products: Recall - Possible Contamination 09/10/2015
Mucinex Fast-MAX Products: Recall - Incorrect Labeling 04/22/2015
Non-aspirin Nonsteroidal Anti-inflammatory Drugs (NSAIDs): Drug Safety Communication - FDA Strengthens Warning of Increased Chance of Heart Attack or Stroke 07/09/2015
4mg Norepinephrine Bitartrate (16mcg/mL) Added to 0.9% Sodium Chloride in 250mL Viaflex Bag and 8mg Norepinephrine Bitartrate (32mcg/mL) Added to 0.9% Sodium Chloride in 250mL Viaflex Bag by Pharmedium: Recall - Discoloration 12/31/2015
Over-the-Counter Asthma Products Labeled as Homeopathic: FDA Statement - Consumer Warning About Potential Health Risks 03/19/2015
Picato (ingenol mebutate) Gel: Drug Safety Communication - FDA Warns of Severe Adverse Events, Requires Label Changes 08/21/2015
Plavix (clopidogrel): Drug Safety Communication - Long-term Treatment Does Not Change Risk of Death 11/06/2015
Potiga (ezogabine): Drug Safety Communication - FDA Determines 2013 Labeling Adequate to Manage Risks of Retinal Abnormalities, Potential Vision Loss, and Skin Discoloration 06/16/2015
Products from Prescription Center Pharmacy in Fayetteville, N.C.: Recall - Lack of Sterility Assurance 04/02/2015
Prescription and Over-the-Counter (OTC) Pain Medicines: Drug Safety Communication - FDA Review of Possible Risks of Pain Medicine Use During Pregnancy 01/09/2015
Proglycem (diazoxide): Drug Safety Communication - Reports of Pulmonary Hypertension in Infants and Newborns 07/16/2015
Prolotherapy with Phenol by Hartley Medical: Recall - Non-sterility Concerns 08/18/2015
Refresh Lacri-Lube, Refresh P.M., FML 0.1 Percent and Blephamide 10 Percent/0.2 Percent by Allergan: Recall - Particulate Matter 08/25/2015
Rosiglitazone-containing Diabetes Medicines: Drug Safety Communication - FDA Eliminates the Risk Evaluation and Mitigation Strategy (REMS) 12/16/2015
SGLT2 Inhibitors: Drug Safety Communication - Labels to Include Warnings About Too Much Acid in the Blood and Serious Urinary Tract Infections 12/04/2015
SGLT2 inhibitors: Drug Safety Communication - FDA Warns Medicines May Result in a Serious Condition of Too Much Acid in the Blood 05/15/2015
Simulated IV Solutions from Wallcur: CDER Statement- FDA's Investigation into Patients being Injected 01/14/2015
Sterile Human and Veterinary Compounded Drugs by Moses Lake Professional Pharmacy: Recall - Lack of Sterility Assurance 07/24/2015
Testosterone Products: Drug Safety Communication - FDA Cautions About Using Testosterone Products for Low Testosterone Due to Aging; Requires Labeling Change to Inform of Possible Increased Risk of Heart Attack And Stroke 05/15/2015
Tramadol: Drug Safety Communication - FDA Evaluating Risks of Using in Children Aged 17 and Younger 09/21/2015
Treanda (bendamustine hydrochloride) Solution by Teva: FDA Statement - Not Compatible with Closed System Transfer Devices, Adapters, and Syringes Containing Polycarbonate or Acrylonitrile-Butadiene-Styrene 09/04/2015
Unapproved Prescription Ear Drop (Otic) Products: Not FDA Evaluated for Safety, Effectiveness and Quality 07/01/2015
Sterile Compounded Products by US Compounding, Inc: Recall - Lack of Sterility Assurance 09/24/2015
Hepatitis C Treatments Viekira Pak and Technivie: Drug Safety Communication - Risk of Serious Liver Injury 10/22/2015
Virazole (Ribavirin Powder For Solution) by Valeant Pharmaceutical North America, LLC: Recall- Due to Microbial Contamination 01/02/2015
Zerbaxa (ceftolozane and tazobactam): Drug Safety Communication - FDA Cautions About Dose Confusion and Medication Errors 05/20/2015
Zyprexa Relprevv (olanzapine pamoate): Drug Safety Communication - FDA Review of Study Sheds Light on Two Deaths Associated with the Injectable Schizophrenia Drug 03/23/2015

Medical Devices

Product NameDate Issued/Updated
Alaris Medley Large Volume Pump (LVP) Frame Membrane by Elite Biomedical Solutions: Class I Recall - Frame Membrane May Allow Over or Under Delivery of Fluid by an Infusion Pump 08/27/2015
Alaris Syringe Pump by CareFusion: Class I Recall - Alarm Error May Cause Interruption of Therapy 08/27/2015
Avea Ventilator by CareFusion: Recall - Potential Malfunction of Pressure Transducer 05/27/2015
Beacon Tip Angiographic Catheters by Cook Medical: Class 1 Recall - Catheter Tip May Slip or Separate 10/13/2015
Bioprosthetic Aortic Valves: FDA Notification - Reduced Leaflet Motion 10/05/2015
Bone Graft Substitutes Containing Recombinant Proteins or Synthetic Peptides in Patients Under Age 18: FDA Safety Communication - Reports of Serious Injuries 01/21/2015
Chariot Guiding Sheath by Boston Scientific: Recall - Risk of Shaft Separation 12/23/2015
Covidien Shiley Neonatal and Pediatric Tracheostomy Tubes by Medtronic: Recall - Tubes Formed With Wider-angle Bend Than Standard Models 07/15/2015
Cranial Perforators With an Automatic Clutch Mechanism: Safety Communication - Failure to Disengage 09/28/2015
Digital Temple Thermometer (DTT) by K-Jump Health Co., Ltd.: Recall - Inaccurate Temperature Display 12/01/2015
Duodenoscope Model TJF-Q180V by Olympus: FDA Safety Communication - New Reprocessing Instructions Validated 01/15/2016
Duodenoscope Reprocessing: FDA Safety Communication - Supplemental Measures to Enhance Reprocessing 08/04/2015
Ebola Virus One-Step Test Kits by LuSys Laboratories: Class I Recall - Not Cleared for Marketing 04/23/2015
ED-530XT Duodenoscopes by FUJIFILM Medical Systems, U.S.A.: Safety Communication - FUJIFILM Medical Systems Validates Revised Reprocessing Instructions 12/23/2015
Endoscope Washer/Disinfectors by Custom Ultrasonics: Safety Communication - FDA Recommends Health Care Facilities Transition to Alternate Reprocessing Methods 02/23/2016
Endoscopic Retrograde Cholangiopancreatography (ERCP) Duodenoscopes: FDA Safety Communication - Design May Impede Effective Cleaning 03/04/2015
Etest PIP/TAZO/CON-4 PTC 256 by bioMérieux: Class I Recall – Potential for Test Result Error 12/29/2015
Evita V500 and Babylog VN500 Ventilators by Dräger Medical: Class I Recall - Faulty Batteries 09/02/2015
FLOW-i Anesthesia Systems by Maquet: Class I Recall - Dislodged Patient Cassette May Stop Patient Ventilation 07/01/2015
Freedom Driver System by SynCardia: Class I Recall - Part May Fail Causing Device to Stop Working 09/18/2015
G5 Ventilator by Hamilton: Class I Recall - Ventilation and Alarm Failure 11/13/2015
Hand-held Laser Pointers: FDA Safety Communication - Risk of Eye and Skin Injuries 12/22/2015
HeartMate II Left Ventricular Assist System (LVAS) by Thoratec Corporation: Urgent Medical Device Correction - Monitor the Backup Battery Expiration Date 09/16/2015
HeartWare Ventricular Assist System: Class I Recall – Updated with Multiple Reasons for Recall 06/22/2015
HeartWare Ventricular Assist System: Class I Recall - Damaged Alignment Guides or Connection Pins May Cause Pump to Stop 06/16/2015
HeartWare Ventricular Assist System Controllers by HeartWare International: Recall - Clinical Trial Controllers Susceptible to Electrostatic Discharge 02/27/2015
Heater-Cooler Devices: FDA Safety Communication - Use of Devices Associated With Nontuberculous Mycobacteria Infections 10/15/2015
Hudson RCI Sheridan Sher-I-Bronch Endobroncial Tube by Teleflex Medical: Class I Recall - Connector May Crack or Separate 08/26/2015
VV13F Reinforced Dual Lumen ECMO Catheters by OriGen Biomedical: Recall - Potential for Separation of Tube from Hub 04/16/2015
Implantable Left Ventricular Assist Devices (LVADs): FDA Safety Communication - Serious Adverse Events 08/05/2015
Inspiration LS, 5i and 7i Ventilator Systems by eVent Medical: Class I Recall - May Shut Down without Alarm 12/07/2015
Intravascular Medical Devices: FDA Safety Communication - Lubricious Coating Separation 11/23/2015
Lariat Suture Delivery Device for Left Atrial Appendage (LAA) Closure by SentreHEART: FDA Safety Communication - Reports of Patient Deaths and Other Serious Adverse Events 07/13/2015
LifeCare PCA3 and PCA5 Infusion Pump Systems by Hospira: FDA Safety Communication - Security Vulnerabilities 05/13/2015
Lifesaver Single Patient Use Manual Resuscitator by Teleflex Hudson RCI: Class I Recall - Intake Port Blockage 07/02/2015
M/L Taper with Kinectiv Technology Prosthesis by Zimmer: Class I Recall - Higher than Expected Levels of Manufacturing Residues 06/19/2015
Magnetic Resonance Imaging (MRI) Systems with Magnet Rundown Unit by GE Healthcare: Class I Recall - Potential Disabling of the Magnet Rundown Unit 02/25/2015
Mammograms at Boston Diagnostic Imaging in Orlanda, Florida: FDA Safety Communication - Quality Problems 08/17/2015
Mammograms at Coastal Diagnostic Center in Pismo Beach, California: FDA Safety Communication - Quality Problems 04/30/2015
Mammograms at Richard D. Adelman M.D. in Raleigh, North Carolina: FDA Safety Communication - Quality Problems 03/24/2015
MAQUET Servo Humidifier 163 by Teleflex Medical: Class I Recall - Cracks in Connector Tubes May Lead to Leak Failures 02/25/2015
Myocardial Protection System (MPS) Delivery Sets by Quest Medical: Recall - Intermittent Seal Failure During Use 10/29/2015
OmniPod Insulin Management System by Insulet: Field Safety Notification - Reported Cases of Needle Mechanism Deployment Failure or Delay 12/23/2015
OxyTOTE Portable Oxygen Unit by Western/Scott Fetzer Company: Class I Recall - May Ignite and Burst 08/18/2015
Perseus A500 Anesthesia Workstation by Draeger: Class I Recall - Faulty Power Switch May Cause Device to Stop Working 12/23/2015
Plum A+ and Plum A+3 Infusion Systems by Hospira: Class I Recall - Alarm Volume Failure 03/06/2015
PROFEMUR Neck Varus/Valgus CoCr 8 Degree, Part number PHAC 1254 by MicroPort Orthopedics: Class I Recall - Unexpected Rate of Fractures After Surgery 10/02/2015
Puritan Bennett 980 Ventilators by Covidien: Class I Recall - Amount of Air Delivered May Be Lower Than Programmed 09/02/2015
RotaWire Elite Guidewire and wireClip Torquer Guidewire by Boston Scientific: Recall - Wires May Break and Separate from the Rotablator System 11/27/2015
Reprocessed Flexible Bronchoscopes: FDA Safety Communication - Risk of Infection 09/17/2015
Symbiq Infusion System by Hospira: FDA Safety Communication - Cybersecurity Vulnerabilities 07/31/2015
Tiger Paw System II by Maquet Medical Systems: Class I Recall - May Cause Tears and Bleeding in Heart Tissue 05/07/2015
Trellis 6 and Trellis 8 Peripheral Infusion Systems by Covidien: Class I Recall - Balloon Inflation Ports Mislabeled 02/11/2015
Unintentional Injection of Soft Tissue Filler into Blood Vessels in the Face: FDA Safety Communication - Risk of Serious Patient Injury 05/28/2015
Vascu-Guard Peripheral Vascular Patch by Baxter: Recall - Difficulty Distinguishing the Smooth from Rough Surface 06/03/2015

Special Nutritional and Cosmetic Products

Product NameDate Issued/Updated
Ayurvedic Dietary Supplements by Shree Baidyanath: Consumer Advice Notice - Products Contain High Levels of Lead and/or Mercury 09/17/2015

Products With Undeclared Drug Ingredients

Product NameDate Issued/Updated
Apexxx by Nuway Distributors: Recall - Undeclared Drug Ingredient 12/23/2015
La' Trim Plus, Jenesis and Oasis by BeeXtreme: Recall - Undeclared Drug Ingredients 12/23/2015
Lipo Escultura: Recall - Undeclared Drug Ingredients 12/04/2015
Miracle Diet 30 and Miracle Rock 48 Capsules by The One Minute Miracle Inc.: Recall - Due to Presence of Undeclared Drug Products 09/11/2015
Pink Bikini Dietary Supplement by Lucy's Weight Loss System: Recall - Undeclared Drug Ingredient 12/09/2015
Smart Lipo: Recall - Undeclared Drug Ingredients 12/18/2015
Various Products Distributed for Weight Loss by Bee Extremely Amazed: Recall - Undeclared Drug Ingredients 12/23/2015

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