Safety

2016 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 Safety Alert Archive, Jan 01 - Dec 31, 2016

Drugs and Therapeutic Biological Products

Product NameDate Issued/Updated
0.25 Percent Bupivacaine Hydrochloride Injection, USP by Hospira: Recall - Particulate Matter 08/05/2016
50 Percent Magnesium Sulfate Injection, USP by Hospira: Recall - Presence Of Particulate Matter 04/14/2016
5 Percent Dextrose Injection USP in PAB Container by B. Braun Medical: Recall - Leakage and/or Particulate Matter 03/29/2016
0.9 Percent Sodium Chloride Solution for Irrigation by Baxter: Recall - Presence of Particulate Matter 02/18/2016
Amikacin Sulfate Injection USP 500 mg/2 mL (250 mg/mL) and 1 Gram/4 mL (250 mg/mL) Vials by Teva: Recall - Glass Particulate Matter 08/03/2016
Amikacin Sulfate Injection USP, 1 gram/4mL (250 mg/mL) Vials by Teva: Recall - Glass Particulate Matter 03/10/2016
Aripiprazole (Abilify, Abilify Maintena, Aristada): Drug Safety Communication - FDA Warns About New Impulse-control Problems 05/03/2016
Baxter IV Solutions (Select Lots): Recall - Potential for Leaking Containers and Particulate Matter 01/27/2016
Baxter IV Solutions: Recall - Potential Presence of Particulate Matter 01/05/2016
BiCNU (carmustine for injection): FDA Alert - Counterfeit Product Discovered in Some Foreign Countries 05/13/2016
Brintellix (vortioxetine): Drug Safety Communication - Brand Name Change to Trintellix, to Avoid Confusion With Antiplatelet Drug Brilinta (ticagrelor) 05/02/2016
Canagliflozin (Invokana, Invokamet): Drug Safety Communication - Clinical Trial Results Find Increased Risk of Leg and Foot Amputations 05/18/2016
Canagliflozin (Invokana, Invokamet) and Dapagliflozin (Farxiga, Xigduo XR): Drug Safety Communication - Strengthened Kidney Warnings 06/14/2016
Cetylev (acetylcysteine) Effervescent Tablets for Oral Solution by Arbor Pharmaceuticals: Recall - Inadequate Seal of Blister Pack 08/18/2016
Chantix (varenicline) and Zyban (bupropion): Drug Safety Communication - Mental Health Side Effects Revised 12/16/2016
Children's Guaifenesin Grape Liquid and Guaifenesin DM Cherry Liquid by Perrigo Company: Recall - Potential Defect with Dosage Cup 01/13/2016
Diabetes Medications Containing Saxagliptin and Alogliptin: Drug Safety Communication - Risk of Heart Failure 04/05/2016
Direct-Acting Antivirals for Hepatitis C: Drug Safety Communication - Risk of Hepatitis B Reactivating 10/04/2016
Family Care Eye Wash by United Exchange Corp: Recall - Microbial Contamination 09/08/2016
Fluoroquinolone Antibacterial Drugs for Systemic Use: Drug Safety Communication - Warnings Updated Due to Disabling Side Effects 07/26/2016
Fluoroquinolone Antibacterial Drugs: Drug Safety Communication - FDA Advises Restricting Use for Certain Uncomplicated Infections 05/12/2016
Eye Wash/Eye Irrigating Solutions Distributed by Major Pharmaceuticals and Rugby Laboratories: Recall - Microbial Contamination 09/07/2016
Eye Drops: FDA Statement - Potential Risk of Loose Safety Seals 03/15/2016
Eyesaline Eyewash by Honeywell: Recall - Microbial Contamination 08/22/2016
Fluconazole (Diflucan): Drug Safety Communication - FDA Evaluating Study Examining Use of Oral Fluconazole (Diflucan) in Pregnancy 04/26/2016
Fluconazole Injection, USP, (in 0.9 Percent Sodium Chloride) 200mg per 100ml: Recall - Elevated Impurity 03/05/2016
General Anesthetic and Sedation Drugs: Drug Safety Communication - New Warnings for Young Children and Pregnant Women 12/14/2016
GlucaGen HypoKit (glucagon [rDNA origin] for injection) by Novo Nordisk Inc: Recall - Detached Needles on Syringe 09/09/2016
HCG and Sermorelin by Talon Compounding Pharmacy: Recall - Lack of Sterility Assurance 07/22/2016
Human and Animal Sterile Drug Products by I.V. Specialty: FDA Alert - Lack of Sterility Assurance 03/09/2016
Hyoscyamine Sulfate 0.125mg by Virtus Pharmaceuticals: Recall - Superpotent and Subpotent Test Results 09/15/2016
Lamotrigine Orally Disintegrating Tablet 200 mg by Impax: Recall - Incorrect Labeling of Blister Cards 08/29/2016
Licorice Coughing Liquid OTC Cough Syrup by Ma Ying Long Pharmaceutical Group: CDER Alert - Contains Unidentified Morphine 01/16/2016
Loperamide (Imodium): Drug Safety Communication - Serious Heart Problems With High Doses From Abuse and Misuse 06/07/2016
Magnesium Sulfate in Water for Injection by Hospira: Recall - Incorrect Barcode Labeling on the Primary Container 01/06/2016
Metformin-containing Drugs: Drug Safety Communication - Revised Warnings for Certain Patients With Reduced Kidney Function 04/08/2016
Morphine Sulfate 0.5 mg/mL Preservative Free in 0.9 percent Sodium Chloride by Pharmakon Pharmaceuticals: Recall - Super-potent Product 02/17/2016
Noxafil (posaconazole): Drug Safety Communication - Dosing Errors when Switching between Different Oral Formulations; Label Changes Approved 01/04/2016
Olanzapine: Drug Safety Communication - FDA Warns About Rare But Serious Skin Reactions 05/10/2016
Opioid Pain or Cough Medicines Combined With Benzodiazepines: Drug Safety Communication - FDA Requiring Boxed Warning About Serious Risks and Death 08/31/2016
Opioid Pain Medicines: Drug Safety Communication - New Safety Warnings Added to Prescription Opioid Medications 03/22/2016
Oral Liquid Docusate Sodium by PharmaTech : Recall - Contaminated with B. Cepacia 07/16/2016
Over-the-Counter Antacid Products Containing Aspirin: FDA Drug Safety Communication - Serious Bleeding Risk 06/06/2016
Oxacillin for Injection, USP, 10g by Sagent: Recall - Iron Oxide Particulate Matter 08/19/2016
Liquid Drug and Dietary Supplement Products by PharmaTech: Recall - Risk of Product Contamination 08/09/2016
PharMEDium Sterile Preparations Compounded With a Single Recalled Lot of Fresenius Kabi Sensorcaine-MPF (bupivacaine HCl): Recall - Presence of Glass Particulate Matter 05/09/2016
Pioglitazone-containing Medicines: Drug Safety Communication - Updated FDA Review, Increased Risk of Bladder Cancer 12/12/2016
Compounded Products by Reliable Drug Pharmacy: Recall - Potential for Mislabeling and Lack of Quality Assurance 03/28/2016
Sensorcaine-MPF (bupivacaine HCl) by Fresenius Kabi: Recall - Presence of Particulate Matter 04/26/2016
Sodium Bicarbonate Injection, USP by Hospira: Recall - Particulate Matter 03/21/2016
Sterile Drug Products by Cantrell Drug Company: Recall - Lack of Sterility Assurance 11/21/2016
Sterile Drug Products by Medaus Pharmacy: FDA Alert - Lack of Sterility Assurance 04/01/2016
Sterile Drug Products from Pharmakon Pharmaceuticals: Recall - Lack of Sterility Assurance 04/16/2016
Syrspend SF and Syrspend SF Grape Suspending Agents by Fagron: FDA Alert - Microbial Contamination with Yeast 02/10/2016
Testosterone and Other Anabolic Androgenic Steroids (AAS): FDA Statement - Risks Associated With Abuse and Dependence 10/25/2016
Tri-Coast Pharmacy Sterile Products: Recall - Lack of Sterility Assurance 11/21/2016
Unexpired Sterile Human and Animal Compounded Products by Abbott's Compounding Pharmacy: Recall - Lack of Sterility Assurance 01/16/2016
Well Care Compounding Pharmacy Sterile Compounded Products: Recall - Lack Of Sterility Assurance 05/18/2016
Sterile Products by Wells Pharmacy Network: Recall - Concern for Lack of Sterility Assurance 09/22/2016
Zecuity (sumatriptan) Migraine Patch: Drug Safety Communication - FDA Evaluating Risk of Burns and Scars 06/02/2016

Medical Devices

Product NameDate Issued/Updated
50mm 0.2 Micron Filters by Baxter: Recall - Potential for Missing Filter Support Membrane, Particulate Matter 10/03/2016
Angiodynamics Soft Vu Omni Flush Angiographic Catheter by Stryker Sustainability Solutions (formerly Ascent Healthcare Solutions): Class I Recall - Tip Separation 07/22/2016
Arrow International Intra-Aortic Balloon Catheter Kits and Percutaneous Insertion Kits by Teleflex Incorporated : Class I Recall - Sheath Body may become Separated from Sheath Hub 03/11/2016
AVEA Ventilator by CareFusion: Class I Recall - Electrical Issue May Cause Unexpected Shutdown 07/28/2016
Beacon Tip Technology Catheters by Cook Medical: Recall - Polymer Degradation of the Catheter Tip 05/04/2016
Beacon Tip Angiographic Catheters by Cook Medical: Class 1 Recall - Catheter Tip May Slip or Separate 10/13/2015
Brainlab Cranial Image-Guided Surgery (IGS) System: Class I Recall - Navigation Inaccuracy 01/15/2016
Capnostream 20 and Capnostream 20p Patient Monitor Battery Packs by Medtronic Respiratory and Monitoring Solutions: Class I Recall - Potential Fire Risk 05/27/2016
Central Venous Catheters and Pressure Monitoring Sets and Trays by Cook Medical: Recall - Catheter Tip Fracture and/or Separation 02/11/2016
Comfort Shield Barrier Cream Cloths by Sage Products: Recall - Product Contamination 08/17/2016
Convenience Kits containing Multi-Med Single Lumen Catheters by Centurion: Class I Recall - Excess Material May Split or Separate 12/09/2016
Covidien Oridion Labeled Capnostream 20 and Capnostream 20p Patient Monitor Battery Packs by Medtronic: Recall - Risk of Thermal Damage 04/20/2016
Dialog+ Hemodialysis Systems by B. Braun Medical: Class I Recall - Defective Conductivity Sensors 05/04/2016
Duodenoscope Models TJF-160F and TJF-160VF by Olympus: Safety Communication - Reprocessing Instructions Validated 03/15/2016
Duodenoscope Model TJF-Q180V by Olympus: FDA Safety Communication - New Reprocessing Instructions Validated 01/15/2016
ED-3490TK Video Duodenoscope by Pentax: FDA Safety Communication - Pentax Validates Reprocessing Instructions 02/19/2016
Essure Permanent Birth Control System by Bayer Healthcare: FDA Announcement - Label Changes 11/15/2016
Evita V500 and Babylog VN500 Ventilators by Dräger: Class I Recall - Issue with Optional PS500 Battery Power Supply May Cause Ventilators to Shut Down Unexpectedly 01/06/2016
Fetch 2 Aspiration Catheter by Boston Scientific: Recall - Shaft Breakage 04/11/2016
FindrWIRZ Guidewire System by SentreHeart: Class I Recall - Coating Separation 11/22/2016
Focus Diagnostics Laboratory Examination Kits: Class I Recall - Inaccurate Test Results 04/14/2016
G4 Platinum and G5 Mobile Continuous Glucose Monitoring System Receivers by Dexcom: Class I Recall - Audible Alarm Failure 04/11/2016
GlideScope Titanium Single-Use Video Laryngoscope by Verathon: Class I Recall - Potential Video Feed Disruption 03/18/2016
Guardian II Hemostasis Valves by Vascular Solutions, Inc: Recall - Risk of Air Leakage 04/11/2016
HeartWare Ventricular Assist Device (HVAD) Pumps by HeartWare Inc.: Class I Recall - Loose Connectors May Prevent Alarm from Sounding 10/28/2016
HeartWare Ventricular Assist Device (HVAD) Pumps by HeartWare Inc.: Class I Recall - Contamination Causing Electrical Issues 10/24/2016
HeartWare Ventricular Assist Device (HVAD) Batteries by HeartWare Inc.: Class I Recall - Premature Power Depletion 06/29/2016
Hummi Micro-Draw Blood Transfer Device by Hummingbird Med Devices: Class I Recall - Potential for Parts to Disconnect 05/26/2016
Implantable Cardioverter Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) by St. Jude Medical: FDA Safety Communication - Batteries May Fail Earlier Than Expected 10/11/2016
INRatio and INRatio2 PT/INR Monitor System by Alere: Recall - Potentially Inaccurate INR Results 07/12/2016
Interference between Computed Tomography (CT) and Electronic Medical Devices: Notification – Current Understanding of Potential Risk 04/01/2016
I.V. Flush Syringes by Nurse Assist: Recall - Potential Link to Burkholderia Cepacia Bloodstream Infections 10/05/2016
Mass Spectrometers by Sciex: Safety Communication - Incorrect Assignment of Test Results 09/01/2016
Medtronic Neurovascular Products: Recall - Potential Separation and Detachment of Polytetrafluoroethylene (PTFE) Coating 10/18/2016
MitraClip Delivery System by Abbott: Safety Notice - Reinforcement of Proper Procedures to Operate and Deploy 02/29/2016
MOVES Ventilator System by Thornhill Research: Class I Recall - Battery Problem 01/27/2016
Neurosurgical Head Holders (Skull Clamps) : FDA Safety Communication - Device Slippage 02/25/2016
NucliSENS easyMAG Magnetic Silica for Nucleic Acid Extraction by BioMerieux: Recall - Potential Inaccurate Test Results 08/12/2016
Optisure Dual Coil Defibrillation Leads by St. Jude Medical: Class I Recall - Damage May Prevent Patient Therapy 01/26/2016
Ovarian Cancer Screening Tests: Safety Communication - FDA Recommends Against Use 09/07/2016
Oxylog 2000 Plus, 3000, and 3000 Plus Emergency Transport Ventilators by Dräger Medical: Class I Recall - System Error May Lead to a Halt in Ventilation Therapy 02/10/2016
OxySure Portable Emergency Oxygen System, Model 615 by OxySure Therapeutics, Inc: FDA Safety Communication - Do Not Use 03/29/2016
Pleural and Pneumopericardial Drainage Sets by Stryker Fuhrman - Class I Recall - Catheter May Break During Insertion 01/11/2016
Programmable Syringe Pumps: FDA Safety Communication - Problems With Fluid Flow Continuity at Low Infusion Rates 08/25/2016
Radiation Therapy Devices by Multidata Systems International: Discontinue Use – Concerns about Risks to Patients 10/20/2016
Roadrunner UniGlide Hydrophilic Wire Guides by Cook Medical: Recall - Raw Materials Issue 09/06/2016
Skintact DF29N Multi-function Defibrillation Electrodes by Leonhard Lang: Class I Recall - Connector Compatibility Issue 10/14/2016
Small Battery Drive and Small Battery Drive II Adaptor and Light Adaptor by DePuy Synthes: Class I Recall - Possible Explosion Risk 09/28/2016
Stӧckert 3T Heater-Cooler System by LivaNova PLC (formerly Sorin Group Deutschland GmbH): UPDATED Safety Communication - Reports of Mycobacterium Chimaera Infections 10/13/2016
SPOTCHEM II Test Strips by Arkray: Class I Recall - Inaccurate Blood Sugar Readings 01/28/2016
Standard Offset Cup Impactor with POM-C Handle by Greatbatch Medical: Class I Recall - Inadequate Sterilization 12/20/2016
Stӧckert 3T Heater-Cooler System by Sorin Group Deustchland GmbH: Safety Communication - Reports of Mycobacterium Chimaera Infections 06/01/2016
Surgical Convenience Packs and Trays by Customed, Inc.: FDA Safety Communication - Do Not Use 01/05/2016
System 83 Plus Automated Endoscope Reprocessors by Custom Ultrasonics: FDA Safety Communication - FDA Recommends Stop Using for Reprocessing Duodenoscopes 08/17/2016
TAH-t Companion 2 Driver System (C2) and Freedom Driver System by SynCardia Systems: Letter to Health Care Providers - Mortality and Neurological Adverse Event Results 10/26/2016
Twin-Pass Dual Access Catheters by Vascular Solutions: Recall - Potential for Excess Manufacturing Material At The Tip 10/05/2016
Urogynecologic Surgical Mesh Implants by Boston Scientific: Notification – Potential for Counterfeit Raw Material 04/01/2016
Vascu-Guard Peripheral Vascular Patch by Baxter International: Letter to Health Care Providers - Potential Risk of Severe Bleeding and Hematomas 07/06/2017
VentStar Oxylog 3000 Pediatric Patient Breathing Circuit by Dräger: Class I Recall - Potential Valve Leakage 08/05/2016
Willy Rusch Tracheostomy Tube Set by TeleFlex Medical: Class I Recall - Possible Disconnection During Patient Use 10/20/2016
ZIKV Detect IgM Capture ELISA by InBios International, Inc: FDA Safety Communication - Wait for Confirmatory Test Results Before Making Patient Management Decisions 12/23/2016

Special Nutritional and Cosmetic Products

Product NameDate Issued/Updated
Bentonite Me Baby – Bentonite Clay by Alikay Naturals: Consumer Warning - Risk of Lead Poisoning 01/28/2016
Best Bentonite Clay by Best Bentonite: FDA Alert - Risk of Lead Poisoning 03/23/2016
Crema Piel De Seda (Silky Skin Cream) by Viansilk: Consumer Warning - Risk of Mercury Poisoning 01/28/2016
DHZC-2 Tablet by Ton Shen Health: Recall - Possible Health Risk 08/12/2016
Dietary Supplements by Ton Shen Health/Life Rising: Recall - Elevated Lead Levels 08/30/2016
DMAA Net Weight 500g by NutriVitaShop: Recall - Presence of DMAA May Pose Health Risk 11/26/2016
GNC Women’s Ultra Mega Time Release 180 count Dietary Supplement by Nutra Manufacturing: Recall - Undeclared Milk 11/18/2016
Homeopathic Teething Tablets and Gels: FDA Warning - Risk to Infants and Children 09/30/2016
L.G Compounded Asafoetida Powder by Shakti Group: Recall - Potential Contamination with Salmonella 01/08/2016
Nature Made (Various Products) by Pharmavite LLC: Recall - Possible Health Risk 06/08/2016
NOW Health Group Dietary Supplements: Recall - Mislabeling 03/22/2016
Products Containing Belladonna Extract by Raritan Pharmaceuticals: Recall - Possible Belladonna Alkaloids 11/25/2016
Side Head Regulator TT Tablet by Life Rising/Ton Shen Health: Recall - Elevated Levels of Lead 11/08/2016
WEN by Chaz Dean Cleansing Conditioners: FDA Statement - Investigation of Adverse Event Reports 07/19/2016

Products With Undeclared Drug Ingredients

Product NameDate Issued/Updated
Continuum Labs LGD-4033 by Invisiblu International: Recall - Investigational Drug Not Approved for Use 04/05/2016
Dream Body 450mg, Dream Body Extreme Gold 800mg, Dream Body Advanced 400mg: Recall - Undeclared Drug Ingredient 07/05/2016
Making It A Lifestyle, L.L.C. Supplements 3rd Degree, Black Gold X Advanced, and Black Label X: Recall - Undeclared Drug Ingredients 05/02/2016
Megajex Natural Male Sex Enhancer by MS Bionic: Recall - Undeclared Drug Ingredients 12/01/2016
Multiple Products by R Thomas Marketing: Recall - Undeclared Drug Ingredient 01/09/2016
Pink Bikini and Shorts on The Beach Dietary Supplements by Lucy's Weight Loss System: Recall - Undeclared Drug Ingredient 01/29/2016
Skinny Bee Diet by Love My Tru Body: Recall - Undeclared Drug Ingredients 11/08/2016
SOS Telecom Products: Recall - Undeclared Drug Ingredient 05/13/2016
Step 2 60 Gold by The Body Shot Bar: Recall - Undeclared Drug Ingredients 06/07/2016
Super Herbs Capsules: Recall - Undeclared Drug Ingredients 04/12/2016
Ultimate Body Tox PRO: Recall - Undeclared Drug Ingredient 12/01/2016

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