Safety

2018 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
95% Ethyl Alcohol Product by Ethanol Extraction: Recall - Due to a Possible Contamination with Methanol 05/23/2018
Acyclovir 400mg Tablets by Apace Packaging: Recall - Product Mix-up 02/13/2018
Alka-Seltzer Plus Products: Recall - Ingredients on Front Sticker May Not Match Product in Carton 03/16/2018
Ampicillin and Sulbactam for Injection USP, 3 g Single-Dose Vials by AuroMedics Pharma: Recall - Presence of Red Particulate Matter 05/08/2018
Ampicillin and Sulbactam for Injection USP 1.5 g/vial by Auromedics: Recall - Presence of Glass Particles in Vial 01/04/2018
Becton-Dickinson (BD) Syringes Used to Store Compounded or Repackaged Drugs: FDA Alert - Problematic Rubber Stoppers Replaced 01/12/2018
Clarithromycin (Biaxin): Drug Safety Communication - Potential Increased Risk of Heart Problems or Death in Patients With Heart Disease 02/22/2018
Clopidogrel Tablets USP, 75 mg by International Laboratories: Recall - Product Mislabeling 01/10/2018
Compounded Drug Products from Cantrell Drug Company: FDA Warning - Serious Deficiencies in Quality and Sterility Assurance 03/02/2018
Compounded Sterile Products by PharMEDium Services: Recall - Lack of Sterility Assurance 01/02/2018
Gericare Eye Wash by Kareway Products: Recall - Potential Product Contamination 02/02/2018
Homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir by MBI Distributing: Recall - Due to a Lack of Adequate Controls 05/21/2018
Hydromorphone HCL Injection USP by Hospira: Recall - Potential For Empty Or Cracked Glass Vials 03/05/2018
Imodium (loperamide) for Over-the-Counter Use: Drug Safety Communication - FDA Limits Packaging To Encourage Safe Use 01/30/2018
Keytruda (pembrolizumab) or Tecentriq (atezolizumab): FDA Alerts Health Care Professionals and Investigators: FDA Statement - Decreased Survival in Some Patients in Clinical Trials Associated with Monotherapy 05/18/2018
Kratom-containing Powder Products by PDX Aromatics: Recall - Potential for Contamination with Salmonella 03/23/2018
Labetalol Hydrochloride Injection by Hospira: Recall - Potential For Cracked Glass At Rim Surface Of Vials 02/23/2018
Lamictal (lamotrigine): Drug Safety Communication - Serious Immune System Reaction 04/25/2018
Levofloxacin in 5 Percent Dextrose 250mg/50mL by AuroMedics: Recall - Presence of Visible Particulate Matter 01/18/2018
Methylprednisolone Sodium Succinate for Injection 40mg, 125mg, and 1g by Sagent Pharmaceuticals: Recall - High Out of Specification Impurity Results 03/06/2018
Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL in the Carpuject™ Single-use Cartridge Syringe System by Hospira: Recall - Due to the Potential Presence of Particulate Matter 06/04/2018
Ocaliva (obeticholic acid): Drug Safety Communication - Boxed Warning Added To Highlight Correct Dosing 02/01/2018
Oral Over-the-Counter Benzocaine Products: Drug Safety Communication - Risk of Serious and Potentially Fatal Blood Disorder 05/23/2018
Pasta De Lassar Andromaco Skin Protectant 25 Percent Zinc Oxide by MarcasUSA: Recall - Potential Contamination 04/02/2018
Piperacillin and Tazobactam for Injection, USP 3.375 g Vials by AuroMedics Pharma LLC: Recall - Vials Contain Particulate Matter 05/08/2018
Prescription Opioid Cough and Cold Medicines: Drug Safety Communication - FDA Requires Labeling Changes 01/11/2018
Sterile Injectable Products by Premier Pharmacy Labs: Recall - Lack of Sterility Assurance 04/12/2018
Varubi (rolapitant) Injectable Emulsion: Health Care Provider Letter - Anaphylaxis and Other Serious Hypersensitivity Reactions 01/16/2018
Juluca, Tivicay, Triumeq (dolutegravir): FDA to Evaluate - Potential Risk of Neural Tube Birth Defects 05/18/2018
X-Jow and Acne Shave Products by Shadow Holdings: Voluntary Recall - Due to Possible Bacterial Contamination 05/29/2018
TAYTULLA (norethindrone acetate and ethinyl estradiol capsules and ferrous fumarate capsules) by Allergan: Recall - Due to Out of Sequence Capsules 05/29/2018
Fluticasone Propionate Nasal Spray by Apotex Corp: Recall - Due to Potential for Small Glass Particles 05/31/2018
Compounded Products Containing Triamcinolone-Moxifloxacin by Guardian Pharmacy Services (Dallas, Texas): Alert to Health Professionals - Adverse Events Reported After Receiving Eye Injections 06/14/2018
Fluoroquinolone Antibiotics: FDA Requires Labeling Changes Due to Low Blood Sugar Levels and Mental Health Side Effects 07/10/2018
Valsartan-Containing Products: Update Health Professional and Consumer on Recent Recalled Products 07/19/2018
Zithromax, Zmax (azithromycin): FDA Warning - Increased Risk of Cancer Relapse With Long-Term Use After Donor Stem Cell Transplant 08/03/2018
SGLT2(sodium-glucose cotransporter-2) Inhibitors for Diabetes: Drug Safety Communication - Regarding Rare Occurrences of a Serious Infection of the Genital Area 08/29/2018
Gilenya (fingolimod): Drug Safety Communication - Severe Worsening of Multiple Sclerosis After Stopping the Medicine 11/20/2018

Medical Devices

Product NameDate Issued/Updated
AirLife Humidification Chamber, Heated Breathing Circuit Kits by Vyaire Medical: Class I Recall - Manufacturing Error 01/31/2018
Cardiac Resynchronization Therapy with Defibrillation (CRT-Ds) and Implantable Cardiovert-Defibrillators (ICDs) by Medtronic: Class I Recall- Manufacturing Error Preventing Electrical Shock Delivery 02/27/2018
Certain Implantable Cardiac Devices by Abbott (formerly St. Jude Medical): FDA Safety Communication - Battery Performance Alert and Cybersecurity Firmware Updates 04/17/2018
Certitude Delivery System by Edwards Lifesciences: Class I Recall - Mold Overflow Defect Which May Obstruct Blood Flow 01/11/2018
Essure Permanent Birth Control System by Bayer Healthcare: Announcement - FDA Restricts the Sale and Distribution 04/09/2018
Extracorporeal Photopheresis (ECP) Treatment : Letter to Health Care Providers - Death and Pulmonary Embolism 02/05/2018
Feeding Tube Placement Systems: Letter to Health Care Providers - Reports of Pneumothorax Events 01/12/2018
HeartStart MRx Defibrillator by Philips Electronics: Class I Recall - Defects in Gas Discharge Tubes May Cause Device Failure 02/09/2018
Liquid-filled Intragastric Balloons by Apollo Endosurgery and ReShape Lifesciences: Letter to Health Care Providers - New Labeling About Potential Risks 06/04/2018
Magnetic Resonance-guided Laser Interstitial Thermal Therapy (MRgLITT) Devices: Letter to Health Care Providers - Risk of Tissue Overheating Due to Inaccurate Magnetic Resonance Thermometry 04/25/2018
NeuroBlate Probe by Monteris Medical: Letter to Health Care Providers, Class I Recall - Unintended Heating 03/22/2018
Neurovascular Embolization Coils: Healthcare Provider Letter - Potential for Increased Image Artifact When Using Magnetic Resonance Angiography For Follow-Up 03/12/2018
Pentax Medical Duodenoscope Model ED-3490TK: FDA Safety Communication - Updated Design and Labeling Cleared 02/07/2018
STAT-Check and Medline Manual Resuscitator Bags by SunMed Holdings: Recall - Patient Port May Detach During Use 06/01/2018
Reprocessed Agilis Steerable Introducer Sheath by Sterilmed: Class I Recall - Improper Seal of Sheath Hub 01/02/2018
System 83 Plus Automated Endoscope Reprocessors (AERs) by Custom Ultrasonics: FDA Safety Communication - Completed Validation Testing 04/10/2018
Zoll LifeVest 4000 Wearable Cardioverter Defibrillator: FDA Safety Communication - Potential Lack of Treatment (Shock) Delivery Due to Device Failure 01/17/2018
BD Vacutainer Blood Collection Tubes by Becton, Dickinson and Company (BD): Class I Recall - Chemical Interference with Certain Tests 03/23/2018
24-Hour Multi-Patient Use Endoscope Connectors: Letter to HealthCare Providers and Healthcare Facilities - Risk of Cross-Contamination 04/18/2018
Vyaire Medical AirLife Resuscitation Device & Broselow Convenience Kit by Vyaire Medical: Class I Recall - Due to Risk of Malfunction Caused by Error in Product Design 05/11/2018
Fabius Anesthesia Machines by Dräger Medical: Class I Recall - Due to Production Step Error 05/09/2018
Neurovascular Stents Used for Stent-Assisted Coiling (SAC): Letter to Health Care Providers - Recommendations Associated With the Use of These Devices in the Treatment of Unruptured Brain Aneurysms 05/08/2018
MindFrame Capture LP Revascularization Device by Medtronic: Class I Recall - Due to Wire Material That May Break or Separate During Use 05/18/2018
HeartMate 3™ Left Ventricular Assist System: Class I Recall - Due to Potential Malfunction that may Lead to Graft Occlusion 05/22/2018
CARDIOSAVE Hybrid Intra-aortic Balloon Pump by Maquet Datascope Corp.: Class I Recall - Due to Fluid Ingress that May Affect Device Operation and Interrupt or Delay Therapy 06/06/2018
Various Aortic Endovascular Graft Systems: Letter to Health Care Providers - UPDATE on Type III Endoleaks 06/19/2018
Risks Associated with Use of Rupture of Membranes Tests - Letter to Health Care Providers 08/08/2018
Temporary Total Artificial Heart Companion 2 Driver System by SynCardia Systems: Letter to Health Care Providers - Risk of Mortality and Stroke 08/17/2018
Implanted Pumps: Safety Communication - Use Caution When Selecting Pain Medicine for Intrathecal Administration 11/14/2018

Special Nutritional and Cosmetic Products

Product NameDate Issued/Updated
Arthri-D 120ct Dietary Supplement by Arthri-D: Recall - Possible Salmonella Contamination 01/24/2018
Bella Diet Capsules by Bella All Natural: Recall - Presence of Sibutramine 02/27/2018
Dietary Supplements by Nutrizone: Recall - Potential for Salmonella Contamination 04/20/2018
Eclipse Kratom by Tamarack: Recall - Possible Salmonella Contamination 03/26/2018
Euphoric Capsules by Epic Products: Recall - Undeclared Sildenafil and Tadalafil 04/18/2018
Kratom-containing Products by Triangle Pharmanaturals: Mandatory Recall - Risk of Salmonella 04/03/2018
Maeng Da Red Powder and Capsules by Club 13: Recall - Possible Contamination With Salmonella 04/10/2018
Rhino 69 Extreme 50000 by AMA Wholesale: Recall - Presence of Tadalafil 04/18/2018
"Zero For Him" Dietary Supplement by Break Ventures/California Basics: Recall - Possible Salmonella Contamination 01/24/2018
NxtGen Botanicals Maeng Da Kratom by NGB Corp.: Recall - Possible Salmonella Contamination 04/19/2018
Certain Kratom-Containing Powder Products by Viable Solutions: Recall -Possible Salmonella Contamination 04/19/2018
Medline Remedy Essentials No-Rinse Cleansing Foam: Avoid Using - Multistate Outbreak of Burkholderia Cepacia Complex 05/10/2018
7K and Poseidon 4500 by Shoreside Enterprises: Voluntary Recall - Due to Presence of Undeclared Sildenafil and/or Tadalafil 05/18/2018
Kratom (mitragyna speciosa) Powder Products by Gaia Ethnobotanical: Recall - Due to Potential Salmonella Contamination 06/22/2018

Biologics

Product NameDate Issued/Updated
Acrodose PLus and PL Systems by Haemonetics: Recall - Low pH Readings for Platelets Stored in CLX HP Bag 04/13/2018

Page Last Updated: 11/20/2018
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