United StatesGSMS Incorporated Niacin Extended-Release Tablets, USP 1,000 mg, 90‑tablet prescription bottles (NDC 51407-268-90) packaged by GSMS Incorporated and manufactured by Kremers Urban Pharmaceuticals, lots GS065128, GS065844, GS066695, GS067432, GS067993, exp. 01/31/2027 are recalled. The lots were recalled because a 12‑month stability test showed they were out of specification (low) for stage 3 dissolution at the 24‑hour timepoint. Owners should check whether they have these specific NDC/lot numbers and expiration date.
What's being recalled
GSMS Incorporated, NIACIN EXTENDED-RELEASE TABLETS, USP, 1,000 MG, 90 tablets, Rx only, Manufactured by Kremers Urban Pharmaceuticals Inc., a subsidiary of Lannett, Inc., Seymour, IN 47274, Packaged by GSMS Incorporated, Camarillo, CA 93012. NDC 51407-268-90.
Recalling firm: Golden State Medical Supply Inc., Camarillo, CA, United States.
How to identify it
Lots: GS065128, GS065844, GS066695, GS067432, GS067993, expires: 01/31/2027.
The hazard
Failed Dissolution Specifications: During 12-month long-term stability testing, subject lot was out of specification (low) for stage 3 dissolution at the 24-hour timepoint.
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
Within the U.S Market.
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)