United StatesPaxil CR (paroxetine) Extended-Release Tablets 37.5 mg, 30-count bottle (NDC 60505-4379-3), lot TY9494, exp. 05/31/2027, manufactured by Apotex Inc. for Apotex Corp., is affected. The product was recalled because it failed dissolution specifications and did not meet 24-month stability testing acceptance criteria; 6,972 bottles were distributed nationwide in the U.S.
What's being recalled
Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg, 30 count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326, NDC 60505-4379-3
Recalling firm: Apotex Corp., Weston, FL, United States.
How to identify it
Lot # TY9494, Exp Date: 05/31/2027.
The hazard
Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
US Nationwide.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)