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Recall Observatory FDA recall evidence

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

May 29, 2026

Class II

Product summary

Firm
Golden State Medical Supply Inc.
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

    reason.potency_specification_failure · v1.0.0

    out of specification