United StatesPrimidone Tablets, USP 250 mg and 50 mg, 100 tablets (10 x 10 unit dose blister) per carton, Rx only, distributed by American Health Packaging, Columbus, OH (Carton NDCs 68084-203-01 and 68084-202-01; Individual Dose NDCs 68084-203-11 and 68084-202-11) — lots 1027583 (exp 09/30/2027), 1028739 (exp 12/31/2027), and 1025622 (exp 06/30/2027). They were recalled because the active pharmaceutical ingredient was contaminated with trace amounts of Acemetacin API.
What's being recalled
Primidone Tablets, USP, 250 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC: 68084-203-01; Individual Dose NDC: 68084-203-11
Primidone Tablets, USP, 50 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC: 68084-202-01; Individual Dose NDC: 68084-202-11
Recalling firm: Amerisource Health Services LLC, Columbus, OH, United States.
How to identify it
Lot#: 1027583, Exp 09/30/2027 Lot 1028739, exp 12/31/2027; Lot 1025622, exp 06/30/2027
The hazard
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
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
USA 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)