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FDA MedWatch Safety Alerts
Consumers may ingest a product to which they may have an allergy or anaphylactic reaction, an ingredient which may be contraindicated for their condition or they intend to otherwise avoid, with potential for serious health consequences.
Posted: March 16, 2018, 5:00 pm
Compounded Glutamine, Arginine, and Carnitine Product for Injection by United Pharmacy: Compounding Risk Alert - FDA Investigates Two Adverse Events
UPDATED 03/16/2017. Glutamine in United Pharmacy’s compounded GAC 10/100/200 mg/mL product for injection is degrading before the beyond-use date (BUD) of 6 months specified on the product label.
Posted: March 16, 2018, 1:00 pm
Neurovascular Embolization Coils: Healthcare Provider Letter - Potential for Increased Image Artifact When Using Magnetic Resonance Angiography For Follow-Up
Reduced quality of MRA image from increased artifact can result in inaccurate clinical diagnoses (e.g., occlusion status) and subsequent inappropriate medical decisions.
Posted: March 12, 2018, 4:15 pm
Kratom-containing Powder Products by PDX Aromatics: Recall - Potential for Contamination with Salmonella
Salmonella contamination can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.
Posted: March 12, 2018, 3:00 pm
Methylprednisolone Sodium Succinate for Injection 40mg, 125mg, and 1g by Sagent Pharmaceuticals: Recall - High Out of Specification Impurity Results
An elevated impurity has the potential to decrease effectiveness of the product in patients. Posted: 03/06/2018
Posted: March 6, 2018, 5:00 am
Use of or exposure to cracked units may be associated with adverse events such as sharps injury to healthcare professionals.
Posted: March 5, 2018, 7:45 pm
Compounded Drug Products from Cantrell Drug Company: FDA Warning - Serious Deficiencies in Quality and Sterility Assurance
Administration of contaminated or otherwise poor quality drug products can result in serious and life-threatening injury or death.
Posted: March 2, 2018, 12:00 pm
Sibutramine and its active metabolites substantially increase blood pressure and/or pulse rate in some patients and may present significant health risks including heart attack, arrhythmia, and stroke.
Posted: February 27, 2018, 1:00 pm
Cardiac Resynchronization Therapy with Defibrillation (CRT-Ds) and Implantable Cardiovert-Defibrillators (ICDs) by Medtronic: Class I Recall- Manufacturing Error Preventing Electrical Shock Delivery
Delay or inability to deliver a shock to a patient in cardiac arrest or pace a patient’s heart whose heartbeat is too slow could result in serious injury and/or death.
Posted: February 27, 2018, 12:00 pm
Labetalol Hydrochloride Injection by Hospira: Recall - Potential For Cracked Glass At Rim Surface Of Vials
Cracked vials may result in a lack of sterility assurance. Use of or exposure to a non-sterile product may be associated with adverse events such as fever, chills, sepsis or invasive systemic infections in patients.
Posted: February 23, 2018, 8:00 pm
Clarithromycin (Biaxin): Drug Safety Communication - Potential Increased Risk of Heart Problems or Death in Patients With Heart Disease
Prescribers advised to consider using other antibiotics in patients with heart disease.
Posted: February 22, 2018, 2:40 pm
Missing a dose of Acyclovir Tablets could cause a reactivation of a virus being treated.
Posted: February 13, 2018, 10:00 pm
HeartStart MRx Defibrillator by Philips Electronics: Class I Recall - Defects in Gas Discharge Tubes May Cause Device Failure
Continued use of the device in AED mode after failure may lead to serious patient injury or death.
Posted: February 9, 2018, 4:00 pm
Pentax Medical Duodenoscope Model ED-3490TK: FDA Safety Communication - Updated Design and Labeling Cleared
Design changes are intended to reduce the potential for leakage of patient fluids into the closed elevator channel and under the distal cap.
Posted: February 7, 2018, 4:00 pm
Extracorporeal Photopheresis (ECP) Treatment : Letter to Health Care Providers - Death and Pulmonary Embolism
FDA has received seven reports of patients experiencing PE during, or soon after, a treatment.
Posted: February 6, 2018, 12:00 am
Probability of a potentially sight threatening eye infection or impairment.
Posted: February 2, 2018, 1:30 pm
Ocaliva (obeticholic acid): Drug Safety Communication - Boxed Warning Added To Highlight Correct Dosing
FDA is clarifying the current recommendations for screening, dosing, monitoring, and managing PBC patients with moderate to severe liver disease taking Ocaliva.
Posted: February 1, 2018, 5:10 pm
AirLife Humidification Chamber, Heated Breathing Circuit Kits by Vyaire Medical: Class I Recall - Manufacturing Error
Parts of the chamber may split apart into layers, allowing water to overflow the chamber and back up into the patient breathing circuit, which could lead to serious adverse health consequences, including injury or death.
Posted: January 31, 2018, 1:00 pm
Imodium (loperamide) for Over-the-Counter Use: Drug Safety Communication - FDA Limits Packaging To Encourage Safe Use
Reports of serious heart problems and deaths with much higher than recommended doses of loperamide. FDA working with manufacturers to use blister packs or other single dose packaging and to limit number of doses in a package.
Posted: January 30, 2018, 2:00 pm
Limbrel Capsules by Primus Pharmaceuticals: FDA Advisory - Linked to Potentially Life-Threatening Health Problems
UPDATED 01/30/2018. Primus voluntarily recalling all unexpired lots of Limbrel products to the patient (user/consumer) level.
Posted: January 30, 2018, 1:40 pm