E2D(R1) Post-Approval Safety Data: Definitions and Standards for Management and Reporting of Individual Case Safety Reports

MedWatch is made up of voluntary and mandatory reporting on prescription medicines, over-the-counter medicines, non-vaccine biologicals, medical devices, special nutritional products, cosmetics and non-prescription human drug products marketed without an approved application.

Waltham, Mass. – Slade Gorton & Co., Inc, is recalling lot 3896 of Wellsley Farms Farm-Raised Atlantic Salmon sold in 2-lb bags at BJ’s Wholesale Club stores due to the potential for the product to be contaminated with Listeria monocytogenes.
Although healthy individuals may suffer only short-term s

The Food and Drug Administration is advising consumers not to purchase or use Rhino 69 Gummy, a product promoted and sold for sexual enhancement on various websites and possibly in some retail stores.

CGMP/Finished Pharmaceuticals/Adulterated

The U.S. Food and Drug Administration today initiated the process for a label change for acetaminophen (Tylenol and similar products) to reflect evidence suggesting that the use of acetaminophen by pregnant women may be associated with an increased risk of neurological conditions such as autism and

AirLife Infant Heated Wire Circuits heat up gas during ventilation. An included adapter may disconnect when the device reaches operating temperature.