Safety

2017 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.

Drugs and Therapeutic Biological Products

Product NameDate Issued/Updated
25 Percent Dextrose Injection, USP (Infant) by Hospira: Recall - Particulate Matter 04/24/2017
Avella Specialty Pharmacy Unexpired Sterile Injectable Products Labeled “Latex Free”: Recall - Products May Contain Synthetic or Natural Latex 02/24/2017
Brilinta (ticagrelor) 90 mg tablets, 8-count Physician Sample Bottles: Recall of Lot # JB5047 - Due to Report of Another Medicine in One Bottle 05/26/2017
Canagliflozin (Invokana, Invokamet): Drug Safety Communication - Increased Risk of Leg and Foot Amputations 05/16/2017
Certain Homeopathic Teething Products: Recall - Confirmed Elevated Levels of Belladonna 04/13/2017
Chlorhexidine Gluconate: Drug Safety Communication - Rare But Serious Allergic Reactions 02/02/2017
Clindamycin Injection ADD-Vantage Vials by Alvogen: Recall - Lack of Sterility Assurance 06/16/2017
Codeine and Tramadol Medicines: Drug Safety Communication - Restricting Use in Children, Recommending Against Use in Breastfeeding Women 04/20/2017
Edex (alprostadil for injection) 10 mcg 2 Pack by Endo Pharmaceuticals: Recall - Potential Lack of Sterility Assurance 02/27/2017
Eliquis (apixaban) 5 mg tablets: Recall One Lot- Bottle labeled as Eliquis 5 mg was found to contain Eliquis 2.5 mg tablets 06/13/2017
EpiPen and EpiPen Jr Auto-Injector: Recall - Failure to Activate Device 03/31/2017
Gadolinium-based Contrast Agents for Magnetic Resonance Imaging (MRI): Drug Safety Communication - No Harmful Effects Identified With Brain Retention 05/22/2017
General Anesthetic and Sedation Drugs: Drug Safety Communication - FDA Approves Label Changes for Use in Young Children 04/27/2017
HCG (Human Chorionic Gonadotropin) Freeze Dried Vials by Synergy Rx: Recall - Lack of Sterility Assurance 02/15/2017
Ibuprofen Lysine Injection, 20 mg /2 mL (10 mg/mL) by Exela Pharma Sciences: Recall - Particulate Matter 02/09/2017
Mibela 24 Fe Chewable Tablets by Lupin Pharmaceuticals Inc.: Recall - Out of Sequence Tablets and Missing Expiry/Lot Information 05/29/2017
Paliperidone Extended-Release Tablets 3mg by Teva Pharmaceuticals: Recall - Dissolution Test Failure 06/15/2017
Phenobarbital 15 mg Tablets, USP by C.O. Truxton: Recall - Labeling Error on Declared Strength 05/08/2017
PNC-27 Products: FDA Warning – Do Not Use For Treatment or Cure for Cancer 01/12/2017
Potassium Phosphate and Succinylcholine by Advanced Pharma: Recall - Potential Lack of Sterility Assurance 06/22/2017
Sterile Compounded Products by Isomeric Pharmacy Solutions: Recall - Lack of Sterility Assurance 04/06/2017
Sodium Bicarbonate Injection 8.4 Percent USP, Neut (Sodium Bicarbonate 4 Percent Additive Solution), Quelicin (Succinylcholine Chloride Injection USP), and Potassium Phosphates Injection by Hospira: Recall - Potential For Lack Of Sterility Assurance 06/15/2017
Succinylcholine Chloride 20mg/mL 5mL Syringe by Fagron Sterile Services: Recall - Potential Lack Of Sterility Assurance 06/23/2017
Topical Products by Phillips Company: Recall - Due to Concerns of Manufacturing Practices 06/14/2017
Unexpired Nitroglycerin Injection in 5 Percent Dextrose USP by Advanced Pharma in Houston: Recall - Sub Potency 06/15/2017
Vancomycin Hydrochloride for Injection, USP by Hospira: Recall - Particulate Matter in Vial 01/25/2017
Viberzi (eluxadoline): Drug Safety Communication - Increased Risk of Serious Pancreatitis In Patients Without A Gallbladder 03/15/2017

Medical Devices

Product NameDate Issued/Updated
Absorb GT1 Bioresorbable Vascular Scaffold (BVS) by Abbott Vascular: Letter to Health Care Providers - FDA Investigating Increased Rate of Major Adverse Cardiac Events 03/18/2017
Alaris Syringe Pump Module (Large Volume Pump), Model 8100 and AIL Sensor Kits by CareFusion: Class I Recall - Alarm Error 02/09/2017
Balloon angioplasty devices to treat autonomic dysfunction: FDA Safety Communication - FDA concern over experimental procedures 03/08/2017
Breast Implants: Update - Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) 03/21/2017
Comprehensive Reverse Shoulder by Zimmer Biomet: Class I Recall - High Fracture Rate 02/16/2017
Coronary Catheters by Abbott: Recall - Difficulty in Removing Balloon Sheath 05/16/2017
Duodenoscopes by Fujifilm Medical Systems: Safety Communication - Certain Older Models Removed From Clinical Use 01/13/2017
ED-3490TK Video Duodenoscope by Pentax: FDA Safety Communication - UPDATE - Follow Pentax Validated Reprocessing Instructions 01/17/2017
Frameless Stereotaxic Navigation Systems: FDA Safety Communication - Navigational Accuracy Errors 06/15/2017
Halo One Thin-Walled Guiding Sheath by Bard Peripheral Vascular Inc.: Class I Recall - Sheath Separation, Kinking, or Tip Damage 01/30/2017
HeartMate II LVAS Pocket System Controller by Abbott-Thoratec: Class I Recall - Due to Risk of Patient Injury and/or Death during Backup Controller Exchange 05/23/2017
HeartStart MRx Monitor/Defibrillator by Phillips Healthcare: Class I Recall - Electrical Issues 03/24/2017
HeartWare Splice Kit Intended to Repair the Driveline of its Ventricular Assist Device by Medtronic: Recall - May Cause Electrical Issues or Pump Stops 05/05/2017
Implantable Cardiac Devices and Merlin@home Transmitter by St. Jude Medical: FDA Safety Communication - Cybersecurity Vulnerabilities Identified 01/09/2017
Implantable Infusion Pumps in the Magnetic Resonance (MR) Environment: FDA Safety Communication - Important Safety Precautions 01/11/2017
Lifepak 1000 Defibrillators by Physio-Control: Voluntary Field Action - Immediately Remove and Reinstall Battery 03/09/2017
Medrad Intego PET Infusion System Source Administration Sets by Bayer: Corrective Action - Particulates Generated in Vial 01/11/2017
NavLock Tracker by Medtronic: Letter to Healthcare Providers - Patient Injuries Reported 05/03/2017
Newport HT70 and HT70 Plus Ventilators by Medtronic: Field Corrective Action - Ventilator May Reset Spontaneously 05/02/2017
NucliSENS easyMAG Magnetic Silica and NucliSENS Magnetic Extraction Reagents by bioMerieux: Class I Recall - Potential Inaccurate Test Results 01/27/2017
Prelude Short Sheath Introducer by Merit Medical Systems: Class I Recall - Sheath May Separate During Use 03/31/2017
SpF PLUS-Mini and SpF XL IIB Implantable Spinal Fusion Stimulators by Zimmer Biomet: Class I Recall - Potential for Harmful Chemicals 05/30/2017
SPS-1 Static Preservation Solution distributed by Organ Recovery Systems: Safety Communication - FDA Warns Of Potential Contamination 03/09/2017
StrataMR Adjustable Valves and Shunts by Medtronic: Recall - Potential for Under-Drainage of Cerebrospinal Fluid 04/08/2017
SynchroMed II and SynchroMed EL Implantable Drug Infusion Pumps by Medtronic: Class I Recall - Failure of Priming Bolus 03/14/2017
System CS100, CS100i and CS300 Intra-Aortic Balloon Pumps by Datascope: Field Correction - Potential Electrical Test Failure Code 06/19/2017
V60 Non-invasive Ventilator by Respironics: Class I Recall - Unexpected Device Shut Down 05/22/2017
Ventricular Assist Device Controllers and DC Adapter by Medtronic Mechanical Circulatory Support (formerly HeartWare Inc.): Class I Recall - Updated Controller, Power Management Software 05/04/2017
Venture Catheters by Vascular Solutions: Recall - Excess Material May Split or Separate During Use 06/23/2017
Wingman35 Crossing Catheters by ReFlow Medical: Recall - Tip Splitting or Separation 05/03/2017

Special Nutritional and Cosmetic Products

Product NameDate Issued/Updated
Al-Er-G Capsules by MusclMasster: Recall - Contains Banned Substance Ephedra 05/25/2017
Caverflo Natural Herbal Coffee: Recall - Presence of Undeclared Active Pharmaceutical Ingredients 05/26/2017
Herbal and Dietary Supplement Products by Regeneca Worldwide: Recall - Not Manufactured in Compliance with Current Good Manufacturing Practices 03/09/2017
Illegal Cancer Treatments: FDA Warning - Fraudulent Claims of Diagnosis, Treatment, Prevention or Cure 04/25/2017
Tri-Ton by Dynamic Technical Formulations, LLC: Recall - Contains Andarine and Ostarine Drug Ingredients 05/22/2017
Well Balance Xanthium & Siler Combo (Bi Yan Pian) Dietary Supplement by Kingsway Trading Inc.: Recall - Product Contains Banned Ephedra Alkaloids 02/09/2017

Products With Undeclared Drug Ingredients

Product NameDate Issued/Updated
Dietary Supplements for Male Sexual Enhancement by A and H Focal: Recall - Undeclared Drug Ingredient 03/07/2017
GEC Laxoplex Dietary Supplement Capsules by Genetic Edge Compounds: Recall - Presence of Anabolic Steroids 05/08/2017
LaBri’s Body Health Atomic by Envy Me: Recall - Undeclared Drug Ingredient 03/30/2017
Organic Herbal Supply Supplement Products: Recall - Undeclared Drug Ingredients 04/19/2017
XtraHRD Natural Male Enhancement Capsules by Organic Herbal Supply, Inc.: Recall - Undeclared Drug Ingredient 02/22/2017

Page Last Updated: 06/23/2017
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.
Language Assistance Available: Español | 繁體中文 | Tiếng Việt | 한국어 | Tagalog | Русский | العربية | Kreyòl Ayisyen | Français | Polski | Português | Italiano | Deutsch | 日本語 | فارسی | English