FDA DrugsClass II
GSMS Incorporated, NIACIN EXTENDED-RELEASE TABLETS, USP, 1,000 MG, 90 tablets, R...
Published: June 17, 2026Recall ID: D-0587-2026Category: drugsCountry: US
Reason for Recall / 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.
Product Description & Identification
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.
Additional Source Details
| Field | Value |
|---|---|
| City | Camarillo |
| State | CA |
| Openfda › Nui › 1 | N0000175594 |
| Openfda › Nui › 2 | M0014839 |
| Openfda › Unii | 2679MF687A |
| Openfda › Route | ORAL |
| Openfda › Rxcui › 1 | 1098134 |
| Openfda › Rxcui › 2 | 1098141 |
| Openfda › Spl id | 4f87399c-e97f-1fb8-e063-6294a90a509e |
| Openfda › Brand name | NIACIN |
| Openfda › Spl set id | 8eff9205-84ac-e69d-e053-2995a90aad4b |
| Openfda › Package ndc › 1 | 51407-267-90 |
| Openfda › Package ndc › 2 | 51407-268-90 |
| Openfda › Product ndc › 1 | 51407-267 |
| Openfda › Product ndc › 2 | 51407-268 |
| Openfda › Generic name | NIACIN |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Pharm class cs | Nicotinic Acids [CS] |
| Openfda › Substance name | NIACIN |
| Openfda › Pharm class epc | Nicotinic Acid [EPC] |
| Openfda › Manufacturer name | Golden State Medical Supply, Inc. |
| Openfda › Application number | ANDA203899 |
| Openfda › Original packager product ndc › 1 | 62175-320 |
| Openfda › Original packager product ndc › 2 | 62175-322 |
| Event id | 99127 |
| Address 1 | 5187 Camino Ruiz |
| Address 2 | N/A |
| Code info | Lots: GS065128, GS065844, GS066695, GS067432, GS067993, expires: 01/31/2027. |
| Postal code | 93012-8601 |
| Report date | 20260617 |
| Product type | Drugs |
| Product quantity | 2,961 bottles |
| Reason for recall | 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260529 |
| Initial firm notification | |
| Center classification date | 20260611 |
Overview
- Recalling FirmGolden State Medical Supply Inc.
- StatusOngoing
- Risk LevelClass II
- DistributionWithin the U.S Market.