MedWatch Safety Alerts

Alka-Seltzer Plus Products: Recall - Ingredients on Front Sticker May Not Match Product in Carton

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

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

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

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

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

Hydromorphone HCL Injection USP by Hospira: Recall - Potential For Empty Or Cracked Glass Vials

Use of or exposure to cracked units may be associated with adverse events such as sharps injury to healthcare professionals

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

Bella Diet Capsules by Bella All Natural: Recall - Presence of Sibutramine

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

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

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

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

Acyclovir 400mg Tablets by Apace Packaging: Recall - Product Mix-up

Missing a dose of Acyclovir Tablets could cause a reactivation of a virus being treated

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

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

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

Gericare Eye Wash by Kareway Products: Recall - Potential Product Contamination

Probability of a potentially sight threatening eye infection or impairment

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

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

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

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

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