Safety

2014 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, 2014

Drugs and Therapeutic Biological Products

Product NameDate Issued/Updated
Acetaminophen Prescription Combination Drug Products with more than 325 mg: FDA Statement - Recommendation to Discontinue Prescribing and Dispensing 01/14/2014
Acetylcysteine Solution 10 Percent/Roxane: Recall - Glass Particles in Product 02/15/2014
Assured Brand Naproxen Sodium Tablets by Contract Packaging Resources, Inc.: Recall - Packaging Mix-Up 10/22/2014
Bo Ying Compound by Eu Yan Sang (Hong Kong) Ltd: FDA/CDER Statement - Risk of Lead Poisoning 09/26/2014
Alli (60 mg orlistat capsules) by GlaxoSmithKline: Recall - Product Tampering 03/28/2014
Baxter IV Sodium Chloride and Potassium Chloride Solutions: Recall - Particulate Matter 07/18/2014
Calcium gluconate 10 percent Injections by Rx Formulations: Recall - Microbial Contamination 02/07/2014
Captomer and Captomer-250 by Thorne Research: FDA Warning - Potential Health Risks 06/13/2014
CLINIMIX and CLINIMIX E Injection/Baxter: Recall - Particulate Matter in Products 01/06/2014
CUBICIN (daptomycin for injection) by Cubist Pharmaceuticals: Recall - Presence of Particulate Matter 04/18/2014
CUBICIN (daptomycin for injection) 500 mg in 10 mL Single Use Vials: Recall - Foreign Particulate Matter 08/09/2014
Coumadin (warfarin sodium) for Injection by Bristol-Myers Squibb: Recall - Particulate Matter 07/01/2014
Cubicin (daptomycin for injection) 500 mg in 10 mL Single Use Vials: Recall - Presence Of Particulate Matter 08/07/2014
Dermatend Original and Dermatend Ultra: Recall - Safety Concerns 09/02/2014
Dianeal Low Calcium (2.5mEq/L) Peritoneal Dialysis Solution with 2.5 Percent Dextrose 5000mL (Ambu-Flex II): Recall - Presence of Particulate Matter 08/15/2014
DIANEAL PD-2 Peritoneal Dialysis Solution with 1.5 Percent Dextrose 6000mL: Recall - Contamination With Mold 03/06/2014
Dobutamine Injection (250mg/20mL)/Hospira: Recall - Visible Particulates 05/15/2014
Docetaxel: Drug Safety Communication - May Cause Symptoms of Alcohol Intoxication 06/20/2014
Doribax (doripenem): Drug Safety Communication - Risk When Used to Treat Pneumonia on Ventilated Patients 03/06/2014
Effexor XR 150 Mg Extended-Release Capsules (Pfizer) and Venlafaxine HCl 150 Mg Extended-Release Capsules (Greenstone): Recall - Possible Presence of Tikosyn Capsules 03/07/2014
Epidural Corticosteroid Injection: Drug Safety Communication - Risk of Rare But Serious Neurologic Problems 04/23/2014
Eszopiclone Containing Sleep Aids: Drug Safety Communication - Can Cause Next-Day Impairment 05/15/2014
Etomidate Injection/Pfizer-Mylan: Recall - Presence of Particulate Matter and/or Illegible and Missing Lot Number and/or Expiry Date 02/20/2014
Flawless Beauty and Skin Products: Recall - Unapproved Drugs 04/30/2014
Gabapentin Capsules, USP 300 mg, by Aurobindo Pharma USA: Recall - Complaints of Empty Capsules 11/24/2014
Heparin Sodium, 1,000 USP Heparin Units/500 mL (2 USP Heparin Units/mL), In 0.9 percent Sodium Chloride Injection, 500 mL by Hospira: Recall - Particulate Matter 09/12/2014
Highly Concentrated Potassium Chloride Injection, 10 mEq per 100 mL by Baxter: Recall - Mislabeled Overpouch 11/21/2014
Hospira Lactated Ringer's And 5% Dextrose Injection, 1000 ML, Flexible Containers: Recall (One Lot) - Mold Contamination 07/11/2014
Ibuprofen and Oxcarbazepine Tablets by American Health Packaging: Recall - Mislabeled Packaging 07/21/2014
IV Solutions from Wallcur of San Diego: CDER Statement - FDA Warns Health Care Professionals Not to Inject Patients 04/08/2015
Ketorolac Tromethamine Injection, USP, 30mg/ml by Sagent Pharmaceuticals: Recall - Incorrect Labeling 10/06/2014
L-citrulline by Medisca: Alert - Potentially Subpotent Product 02/17/2014
Lidocaine HCI Injection, USP 10 MG Per ML, 30 ML Single-Dose, Preservative-Free, by Hospira: Recall - Particulate Matter 10/17/2014
Lidocaine Viscous: Drug Safety Communication - Boxed Warning Required - Should Not Be Used to Treat Teething Pain 06/26/2014
Lidocaine HCI Injection, USP, 2 percent, by Hospira: Recall - Visible Particulates 07/30/2014
Lidocaine HCI Injection, USP, by Hospira: Recall - Visible Particulates 04/18/2014
LifeCare Flexible Intravenous Solutions by Hospira, Inc.: Recall - Potential for Leakage 10/15/2014
Long-term Antiplatelet Therapy: Safety Announcement - Preliminary Trial Data Shows Benefits But a Higher Risk of Non-Cardiovascular Death 11/16/2014
Marcaine (Bupivacaine HCI Injection, USP), 0.5 percent, 30 ML, Single-Dose, Preservative-Free Vial: Recall - Visible Particulates 06/18/2014
Marcaine (Bupivacaine HCI Injection, USP) 0.25 percent, 10 ml, Single-Dose, Preservative-Free Vial: Recall - Visible Particulates 04/22/2014
Martin Avenue Pharmacy, Inc. Compounded Sterile Preparations: Recall - Lack of Assurance of Sterility 09/02/2014
Medical Supply Liquidators Injectable Vitamin Products With a "Sunshine Labs" Label: Warning - Products Not FDA Approved 06/30/2014
Mitoxantrone by Hospira: Recall - Confirmed Subpotency and Out-Of-Specification 12/23/2014
NaturaLyte Liquid Bicarbonate Concentrate: Recall - Potential Health Risk 05/28/2014
Olmesartan: Drug Safety Communication - FDA Review Finds Cardiovascular Risks for Diabetics Not Conclusive 06/24/2014
Oregon Compounding Centers, Inc. Unexpired Sterile Products: Recall - Lack of Sterility Assurance 10/10/2014
Over-The-Counter Topical Acne Products: Drug Safety Communication - Rare But Serious Hypersensitivity Reactions 06/25/2014
Pharmacy Creations Certain Products: Recall – Potential Non-Sterility 09/06/2014
Potassium Chloride Injection (Baxter): Recall - Shipping Carton Mislabeling 09/17/2014
Pleo Homeopathic Drug Products by Terra-Medica: Recall - Potential for Undeclared Penicillin 03/20/2014
Pradaxa (dabigatran): Drug Safety Communication - Lower Risk for Stroke and Death, but Higher Risk for GI Bleeding Compared to Warfarin 05/13/2014
Propofol Injectable Emulsion, USP by Hospira: Recall - Visible Particulates 04/18/2014
Revatio (sildenafil): Drug Safety Communication - FDA Clarifies Warning About Pediatric Use for Pulmonary Arterial Hypertension 03/31/2014
Rohto Eye Drops - Mentholatum: Recall - Sterility Control Review 01/17/2014
Saxagliptin (marketed as Onglyza and Kombiglyze XR): Drug Safety Communication - FDA to Review Heart Failure Risk 02/11/2014
Sodium Phosphate Over-the-Counter Products: Drug Safety Communication - Possible Harm From Exceeding Recommended Dose 01/08/2014
Testosterone Products: FDA/CDER Statement - Risk of Venous Blood Clots 06/20/2014
0.9 Percent Sodium Chloride Injection USP in 100 mL MINI-BAG PLUS Container by Baxter: Recall - Particulate Matter 12/16/2014
Sodium Chloride IV 0.9 Percent by Baxter: Recall - Particulate Matter 08/13/2014
Soliris (eculizumab) Concentrated Solution for IV Infusion by Alexion: Recall - Visible Particulates 06/02/2014
Sterile Drug Products by Unique Pharmaceuticals Ltd.: Recall - Lack of Sterility Assurance 07/11/2014
Tecfidera (dimethyl fumarate) by Biogen Idec: Drug Safety Communication - Case of Rare Brain Infection PML Reported 11/25/2014
Testosterone Products: Drug Safety Communication - FDA Investigating Risk of Cardiovascular Events 01/31/2014
Vancomycin Hydrochloride for Injection USP, Equivalent to 1 Gram Vancomycin (Sterile Powder) by Hospira, Inc.: Recall - Uncontrolled Storage During Transit 10/08/2014
VPRIV (velaglucerase alfa for injection): Recall - Visible Particulate Matter 03/14/2014
Labetalol Hydrochloride Injection 100 MG/20 ML (5MG/ML), 20 ML, Multidose Vial by Hospira: Recall - Visible Particulates 05/16/2014
Sterile Drug Products by Downing Labs (aka NuVision Pharmacy): Drug Alert - Lack of Sterility Assurance 09/09/2014
Xolair (omalizumab): Drug Safety Communication - Slightly Elevated Risk of Cardiovascular and Cerebrovascular Serious Adverse Events 09/26/2014
Ziprasidone (Marketed as Geodon and Generics): Drug Safety Communication - Rare But Potentially Fatal Skin Reactions 12/11/2014

Medical Devices

Product NameDate Issued/Updated
Medi-Trace Cadence and Kendall Multi-function Defibrillation Electrodes by Covidien: Field Safety Alert - Electrodes Will Not Connect with Philips FR3 or FRx AED units 10/12/2014
GE Healthcare, LLC, Single-Width Airway Modules (E-MiniC) and Accessories and Extension Modules (N-FC, N-FCREC): Class I Recall - CO2 Detector May Fail Leading to Injury 07/25/2014
Abbott Acclaim and Hospira Acclaim Encore Infusion Pumps by Hospira, Inc: Class I Recall - Broken Door Assemblies 05/02/2014
ACME Monaco Guidewire .035x150 3MMJ TCFC, Item 88241 by Medline Industries: Class I Recall - Potential for Coating to Flake Off 02/25/2014
Advanced Sterilization Products Sterrad Cyclesure 24 Biological Indicator: FDA Safety Communication - Product Shortage 05/23/2014
Advocate Redi-Code+ Blood Glucose Test Strips by Diabetic Supply of Suncoast: Recall- Labeling Error 07/22/2014
Alaris Pump Module (Model 8100), Version 9.1.18 Software by CareFusion 303, Inc: Class I Recall - May Not Properly Delay an Infusion 05/21/2014
Alere INRatio2 PT/INR Professional Test Strips: Recall - Higher INR when Performed by Central Laboratory 12/09/2014
ARKON Anesthesia Delivery System with Version 2.0 Software by Spacelabs Healthcare: Class I Recall - Software Defect May Cause System to Stop Working 04/16/2014
Baxter ABACUS TPN Calculation Software: Class I Recall - Software Errors May Cause Toxic/Overdose Symptoms 05/22/2014
Sigma Spectrum Infusion Pumps with Master Drug Library by Baxter Healthcare: Class I Recall - System Error May Interrupt or Delay Therapy 05/02/2014
Big Sky Diagnostic Imaging, LLC in Butte, Montana: FDA Safety Communication - Mammography Problems 06/23/2014
Diamondback 360 Peripheral Orbital Atherectomy System by Cardiovascular Systems: Class I Recall - Sheath May Fracture During Use 08/19/2014
CareFusion EnVe and ReVel Ventilators: Class 1 Recall - Power Connection Failure 10/10/2014
Children’s Medical Ventures Gel-E Donut and Squishon 2: Class 1 Recall - Possibility of Mold 08/22/2014
CloverSnare 4-Loop Vascular Retrieval Snare by Cook Medical: Recall - Risk of Loop to Separate From Shaft 09/04/2014
CO2 Multi Absorber by Vital Signs Devices: Field Corrective Action - Loss of Anesthetic Gases, Ventilation and Oxygenation 01/01/2014
CONMED PadPro and R2 Multi-function Defibrillation Electrodes: Device Correction - Connector Compatibility Issue With Philips FR3 and FRx Defibrillator Units 11/26/2014
ConvaTec, Inc., Flexi-Seal CONTROL Fecal Management System Kit: Class I Recall - Not Cleared for Marketing 06/20/2014
Covidien Pipeline Embolization Device and Alligator Retrieval Device: Recall - Coating on Delivery Wire Could Delaminate 04/11/2014
Puritan Bennett 840 Series Ventilator by Covidien - Class I Recall - Software Problem 01/10/2014
DePuy Synthes Craniomaxillofacial Distraction System: Class I Recall - May Reverse Directions After Surgery 08/28/2014
Expression Injectable by Enhancement Medical: FDA Safety Communication - Adverse Events Associated with Unapproved Use As a Dermal Filler 08/05/2014
Fisher and Paykel Healthcare, Ltd., Infant Nasal CPAP Prongs: Class I Recall - Prongs May Detach from Nasal Tubing and Interrupt Therapy 05/23/2014
FreeStyle and FreeStyle Flash Blood Glucose Meter by Abbott: Recall - May Produce Mistakenly Low Blood Glucose Results 04/14/2014
GE Healthcare Resuscitation Systems: Class I Recall - Oxygen and Air Inlet Fittings Reversed During Assembly 02/28/2014
Gel-E Donut and Squishon 2 Products by Children’s Medical Ventures: Recall - Potential Mold Contamination 12/02/2014
Gemstar Docking Station by Hospira, Inc: Class I Recall - Potential for Error or Failure to Power Up 05/09/2014
GemStar Power Supply, 3VDC for GemStar Infusion Pumps by Hospira: Class I Recall - Power Supply May Not Deliver Enough Electricity 11/05/2014
GenStrip Blood Glucose Test Strips by Shasta Technologies: FDA Safety Communication - May Report False Results 04/29/2014
Greatbatch, Inc. Standard Offset Cup Impactors: Recall - Sterilization Recommendation in Instructions Do Not Meet Sterility Assurance Requirements 03/12/2014
HeartMate II LVAS Pocket System Controller by Thoratec Corporation: Medical Device Correction - Updated Labeling and Training Materials 04/01/2014
Heart Sync Inc. Multi-function Defibrillation Electrodes: Device Correction - Connector Incompatibility with Philips FR3 and FRx Defibrillator Units 12/24/2014
HeartWare, Inc., Heartware Ventricular Assist System: Class I Recall - Locking Mechanism of Pump Driveline Connector May Fail to Engage 04/29/2014
Hudson RCI Pediatric Anesthesia Breathing Circuits by Teleflex Medical: Class I Recall - Circuit Ends May Crack or Break 10/07/2014
HydroFinity Hydrophilic Guidewires by NDC/Covidien: Recall - Outer Jacket Damage 06/25/2014
ICU Medical ConMed Stat2 Flow Controller: Class 1 Recall - Delivers Higher Flow Rate than Intended 10/10/2014
Intravia Containers by Baxter: Recall - Particulate Matter 11/20/2014
IPM Wound Gel by Edwards Pharmaceuticals: Class I Recall - Microbial Contamination 08/12/2014
KimVent Microcuff Subglottic Suctioning Endotracheal Tubes by Halyard Health: Class I Recall - Component May Detach During Use 12/31/2014
Langston V2 Dual Lumen Catheters (Models 5540 and 5550) by Vascular Solutions: Class I Recall - Inner Catheter May Separate During Use and Cause Injury 07/07/2014
Laparoscopic Power Morcellation in Hysterectomy and Myomectomy: FDA Safety Communication - Use Discouraged Due to Increased Risk in Women With Uterine Fibroids 11/24/2014
Maquet Datascope Intra-Aortic Balloon Pumps: Class I Recall - Failure of Fan Assembly 05/22/2014
McKesson Technologies Anesthesia Care: Recall – Patient Case Data May Not Match Patient Data 03/14/2014
Medtronic Duet External Drainage and Monitoring System, Medtronic Neurosurgery: Class 1 Recall - Tubing May Disconnect and Lead to Injury 07/02/2014
Merit Medical Systems, Custom Procedural Trays/Kits Containing 1 percent Lidocaine HCl Injection, USP, 10mg/mL: Recall - Particulates Found in Hospira supplied Lidocaine 03/14/2014
Nellcor Puritan Bennett 980 Ventilator System by Covidien: Class I Recall - Component Failure May Cause Burning Odor 12/31/2014
Nellcor Puritan Bennett, 980 Ventilator System: Class I Recall - Software Issue May Stop Ventilator 11/07/2014
Nephros Filtration Products: Class I Recall - Labeling Promoting Medical Claims 01/07/2014
Playtex Nurser Deluxe Double Electric Breast Pump: Recall - Potential for Electric Shock 09/16/2014
Respironics California, Esprit V1000 and V200 Ventilators: Class I Recall - Power Failure May Occur 11/19/2014
SafeSpout and SafeShower Filtration Products by Nephros: Class I Recall - Exposure to Bacteria or Virus 01/07/2014
SAM Junctional Tourniquet Accessory (Axilla) Strap - SAM Medical Products: Recall - Potential Clip Failure 10/08/2014
Siemens Healthcare Diagnostics, Rapid Gram Negative Combo Panels: Class I Recall - May Produce Incorrect Results 12/02/2014
Smiths Medical Portex Low Dead Space Connector with Sideport, 3.5mm: Class I Recall- One Lot Mislabeled 06/13/2014
Sterile Convenience Surgical Packs by Customed, Inc.: Recall - Potential Loss of Sterility 11/25/2014
ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port (with and without Preloaded Stylet) by Teleflex Medical – Class I Recall: Potential Kinking During Patient Use 02/24/2014
Trilogy Ventilator Models 100, 200 and 202 by Philips Respironics: Recall - Failure to Deliver Mechanical Breaths 02/20/2014
Truebalance and Truetrack Blood Glucose Meters by Nipro Diagnostics: Recall - Incorrect Factory-set Measure 01/08/2014
Trufill n-BCA Liquid Embolic System by Codman Neuro: Recall - Incorrect Instructions For Use 01/22/2014
t:slim Insulin Cartridges by Tandem Diabetes Care: Recall - Potential for Cartridge Leak 01/14/2014
Ventlab Resuscitator Bags: Recall - Possible Health Risk 05/16/2014
10 Percent Neutral Buffered Formalin by Richard-Allan Scientific: Class I Recall - May Contain Incorrect Concentration of Formalin 10/31/2014

Special Nutritional and Cosmetic Products

Product NameDate Issued/Updated
ABC Dophilus Powder by Solgar, Inc: Recall - Risk of Infection 11/17/2014
Dietary Supplements Containing Live Bacteria or Yeast in Immunocompromised Persons: Warning - Risk of Invasive Fungal Disease 12/09/2014
Baby Wipes by Nutek Disposables, Inc.: Recall - May Contain Bacteria 10/27/2014
RegeneSlim Appetite Control Capsules: Recall - Presence Of DMAA 09/02/2014
Saba Shark Cartilage Complex, 60 Capsule Bottles: Recall - Possible Salmonella Contamination 10/20/2014
StemAlive 90 Capsules: Recall - Contains Undeclared Milk 01/19/2014
White and Blue Lion Tattoo Kits: Recall - Bacterial Contamination of Needles and Ink Bottles 08/08/2014

Products With Undeclared Drug Ingredients

Product NameDate Issued/Updated
African Black Ant, Black Ant, and Mojo Risen by Eugene Oregon, Inc: Recall - Undeclared Drug Ingredient 05/29/2014
Arize: Public Notification - Undeclared Drug Ingredient 08/11/2014
Asset Bee Pollen: Public Notification - Undeclared Drug Ingredient 05/12/2014
Asset Bold: Public Notification - Undeclared Drug Ingredient 05/16/2014
Bee Slim: Public Notification - Undeclared Drug Ingredient 11/24/2014
Bee Thin: Public Notification - Undeclared Drug Ingredient 11/24/2014
Bella Vi Brand Products by Pure Edge Nutrition: Recall - Undeclared Drug Ingredients 03/26/2014
Black Storm: Public Notification - Undeclared Drug Ingredient 11/24/2014
B-Lipo Capsules by Bethel Nutritional Consulting, Inc.: Recall - Undeclared Drug Ingredient 12/22/2014
Boost Ultra, XZone Gold, Sexy Monkey, Triple MiracleZen Platinum, Magic for Men,"New" Extenze, and New XZen Platinum Marketed as Dietary Supplements: Recall - Undeclared Drug Ingredients 01/10/2014
Dream Body Slimming Capsule: Public Notification - Undeclared Drug Ingredient 01/22/2014
Forever Beautiful Bee Pollen by REFA Enterprises: Recall - Undeclared Drug Ingredients 11/20/2014
Ginseng Kianpi Pil: Public Notification - Undeclared Drug Ingredients 10/31/2014
Herbal Vigor Quick Fix: Public Notification - Undeclared Drug Ingredient 08/11/2014
Infinity: Public Notification - Undeclared Drug Ingredient 04/11/2014
La Jiao Shou Shen: Public Notification - Undeclared Drug Ingredient 06/11/2014
Lite Fit USA: Public Notification - Undeclared Drug Ingredient 04/11/2014
Magic Slim: Public Notification - Undeclared Drug Ingredient 01/22/2014
Male Sexual Enhancement Products: Immediate Public Notification: Undeclared Drug Ingredients 06/19/2014
Mayhem: Public Notification - Undeclared Drug Ingredients 11/14/2014
Mega Slim Herbal Appetite Management Pills by YoungYou International: Recall - Presence of DMAA 01/31/2014
MV5 Days: Public Notification - Undeclared Drug Ingredient 05/16/2014
Natural Body Solution: Public Notification - Undeclared Drug Ingredient 05/06/2014
New Life Nutritional Center Dietary Supplements: Recall - Undeclared Drug Ingredients 03/26/2014
Nova Products, Inc. Dietary Supplements: Recall - Undeclared Drug Ingredients 03/31/2014
Pro ArthMax by Human Science Foundation: Recall - Undeclared Drug Ingredients 01/14/2014
Reduce Weight Fruta Planta: Recall - Undeclared Drug Ingredient 02/14/2014
Red Yeast Rice by Doctor’s Best: Recall - Undeclared Lovastatin 06/24/2014
Sit and Slim II: Public Notification - Hidden Drug Ingredients 10/10/2014
SLIM-K Capsules by Bethel Nutritional Consulting, Inc.: Recall - Undeclared Drug Ingredients 12/22/2014
Slim Trim U: Public Notification - Undeclared Drug Ingredient 05/06/2014
Super Arthgold by Nano Well-being Health: Recall - Undeclared Drug Ingredients 04/24/2014
Super Extreme Accelerator: Public Notification - Undeclared Drug Ingredient 11/24/2014
S.W.A.G: Public Notification - Undeclared Drug Ingredient 04/18/2014
Thinogenics Products by Nature’s Universe: Recall - Undeclared Drug Ingredient 04/18/2014
V26 Slimming Coffee: Public Notification - Undeclared Drug Ingredient 11/05/2014
Slim-Vie: Public Notification - Undeclared Drug Ingredient 11/26/2014
Vitaccino Coffee: Public Notification - Undeclared Drug Ingredient 03/19/2014
Weight Loss Products: Immediate Public Notification: Undeclared Drug Ingredients 06/19/2014
Weight Loss Products: Public Notification - Undeclared Drug Ingredients 07/09/2014
Zi Xiu Tang Bee Pollen Capsules by Guangzhou Zi Xiu Tang Biotechnology Co., Ltd: Warning - Undeclared Drug Ingredients 04/08/2014

Foods

Product NameDate Issued/Updated
Caramel Apples: Warning - Illnesses, Including Deaths, Linked to Listeria Monocytogenes Contamination 12/25/2014

Page Last Updated: 12/31/2014
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