Drug product
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.
D-0587-2026
Product summary
- Event
- Event 99127
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2,961 bottles
- Official record key
drug-enforcement:D-0587-2026
Official wording
Reason: 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.
Code information: Lots: GS065128, GS065844, GS066695, GS067432, GS067993, expires: 01/31/2027.
Distribution pattern: Within the U.S Market.
Derived failure modes
-
Potency or specification failure
out of specification