United StatesPrimidone Tablets, USP 50 mg (50‑count, NDC 51407‑637‑05) and 250 mg (100‑count, NDC 51407‑638‑01) manufactured by Lannett Company and marketed by Golden State Medical Supply (GSMS) are affected; impacted lot numbers and expiration dates include GS066750, GS067084, GS067710, GS067873 (exp 3/31/2028); GS068339, GS068897 (exp 8/31/2028); GS067909 (exp 4/30/2028); and GS068646 (exp 8/31/2026). They were recalled because the active pharmaceutical ingredient was contaminated with trace amounts of acemetacin.
What's being recalled
Primidone Tablets, USP, 50 mg, 50-count bottle, RX only, Manufactured by: Lannett Company, Inc., Marketed by: GSMS, Incorporated, Camarillo, CA 93012. NDC 51407-637-05
Primidone Tablets, USP, 250 mg, 100-count bottle, RX only, Manufactured by: Lannett Company, Inc., Marketed by: GSMS, Incorporated, Camarillo, CA 93012. NDC 51407-638-01
Recalling firm: Golden State Medical Supply Inc., Camarillo, CA, United States.
How to identify it
Lot#: GS066750, GS067084, GS067710, GS067873, Exp 3/31/2028; GS068339, GS068897, Exp 8/31/2028 Lot #: GS067909, Exp 4/30/2028; GS068646, Exp 8/31/2026
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)