MedWatch Safety Alert

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FDA MedWatch Safety Alerts
Updated: 2 hours 41 sec ago

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

Tue, 02/13/2018 - 16:00
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

Fri, 02/09/2018 - 10:00
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

Wed, 02/07/2018 - 10:00
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

Mon, 02/05/2018 - 18:00
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

Fri, 02/02/2018 - 07:30
Probability of a potentially sight threatening eye infection or impairment.

Ocaliva (obeticholic acid): Drug Safety Communication - Boxed Warning Added To Highlight Correct Dosing

Thu, 02/01/2018 - 11:10
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

Wed, 01/31/2018 - 07:00
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.

Imodium (loperamide) for Over-the-Counter Use: Drug Safety Communication - FDA Limits Packaging To Encourage Safe Use

Tue, 01/30/2018 - 08:00
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.

Limbrel Capsules by Primus Pharmaceuticals: FDA Advisory - Linked to Potentially Life-Threatening Health Problems

Tue, 01/30/2018 - 07:40
UPDATED 01/30/2018. Primus voluntarily recalling all unexpired lots of Limbrel products to the patient (user/consumer) level.

"Zero For Him" Dietary Supplement by Break Ventures/California Basics: Recall - Possible Salmonella Contamination

Wed, 01/24/2018 - 08:00
Salmonella can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

Arthri-D 120ct Dietary Supplement by Arthri-D: Recall - Possible Salmonella Contamination

Wed, 01/24/2018 - 08:00
Salmonella can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.

Nexterone (amiodarone HCl) 150 mg/100 mL Premixed Injection: Recall - Presence Of Particulate Matter

Tue, 01/23/2018 - 08:20
UPDATED 01/23/2018. Recall expanded to include a second lot (NC109123). Intravenous administration of a solution containing sterile particulate matter may lead to adverse health consequences.

Basic Drugs Brand of Senna Laxative by Magno-Humphries Laboratories: Recall - Mislabeling

Sun, 01/21/2018 - 23:00
Unintentional consumption of naproxen sodium potentially could result in fatal adverse events in patients with underlying illnesses. Posted 01/22/2018

Multiple Drug Products by Flawless Beauty: Recall - Misbranded or Unapproved

Sun, 01/21/2018 - 23:00
Misbranded or unapproved new drugs present serious public health risks. Posted 01/22/2018