FDA-Drug2025-11-26Class IIPROCESSING DEFECT

NIACIN Extended-Release Tablets, USP, 1,000 mg, 90 tablets per bottle, Rx only, Manufactured by: Kremers Urban Pharmaceuticals, Inc., a subsidiary of Lannett Company, Inc., Seymour, IN 47274. Packaged by GSMS, Incorporated, Carmarillo, CA 93012. NDC: 51407-268-90

OTHERNationwide distribution
Hazard

Failed Dissolution Specifications

Sold states
Nationwide in the USA
Affected count
24,869 bottles
Manufactured in
5187 Camino Ruiz, Camarillo, CA, United States
Products
NIACIN Extended-Release Tablets, USP, 1,000 mg, 90 tablets per bottle, Rx only, Manufactured by: Kremers Urban Pharmaceuticals, Inc., a subsidiary of Lannett Company, Inc., Seymour, IN 47274. Packaged by GSMS, Incorporated, Carmarillo, CA 93012. NDC: 51407-268-90

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0158-2026

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