United StatesPrimidone Tablets, USP, 50 mg, 100-tablet bottles (NDC 53746-544-01), Lot AM251676, EXP 11/31/2028, manufactured by Amneal Pharmaceuticals Pvt. Ltd. and distributed by Amneal Pharmaceuticals LLC, are being recalled nationwide in the U.S. The recall is due to a potential for cross-contamination with Acemetacin API resulting from an issue at the API manufacturer.
What's being recalled
Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA. Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC: 53746-544-01
Recalling firm: Amneal Pharmaceuticals, LLC, Bridgewater, NJ, United States.
How to identify it
Lot AM251676, EXP 11/31/2028
The hazard
Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.
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
Nationwide within the USA.
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)