Niacin extended-release tablets failed dissolution testing at 24 hours
GSMS Niacin Extended-Release Tablets, USP, 1,000 mg, are being recalled after a lot was out of specification for stage 3 dissolution at the 24-hour timepoint. 2,961 bottles affected.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall for an out-of-specification dissolution result with no clinical consequence described in the source, which fits the Moderate band.
Plain-English summary
Niacin Extended-Release Tablets, USP, 1,000 mg, 90 tablets, prescription only, manufactured by Kremers Urban Pharmaceuticals Inc. of Seymour, Indiana and packaged by GSMS Incorporated of Camarillo, California, are being recalled. The action covers 2,961 bottles.
The stated reason is failed dissolution specifications: during 12-month long-term stability testing, the subject lot was out of specification (low) for stage 3 dissolution at the 24-hour timepoint. The FDA classified the action as Class II. The source does not describe a resulting clinical consequence.
Affected lots are GS065128, GS065844, GS066695, GS067432 and GS067993, expiring 01/31/2027. Distribution was within the US market.
Patients should not stop taking a prescribed medicine without advice. Anyone holding an affected lot should speak to their pharmacist or prescriber and follow the instructions issued by the firm.
The recalled product
- Product
- NIACIN (NIACIN)
- Brand
- NIACIN
- Manufacturer
- Golden State Medical Supply Inc.
- Category
- Drug — Extended-release tablet
- Affected units
- 2,961
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Lots: GS065128
- GS065844
- GS066695
- GS067432
- GS067993
- expires: 01/31/2027.
Distribution
Distribution scope not specified by the agency.
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