Golden State Medical Supply niacin extended-release tablets recalled for failed dissolution
Golden State Medical Supply is recalling specific lots of niacin extended-release tablets (1,000 mg) because they failed to dissolve properly during stability testing. The tablets did not meet dissolution specifications at the 24-hour mark, which means they may not release the medication as intended in the body.
From the FDA notice · Read the official notice ↗ · All Golden State Medical Supply recalls
What to do
- Check if you have niacin tablets from Golden State Medical Supply with lot numbers GS065128, GS065844, GS066695, GS067432, or GS067993 (expiring 01/31/2027).
- Do not stop taking niacin without talking to your doctor or pharmacist.
- Contact your pharmacist or Golden State Medical Supply to return or dispose of affected tablets.
- Talk to your doctor about getting a replacement prescription if needed.
Is yours affected?
Compare your label or packaging with the recalled product.
- 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.
- Sold in
- Nationwide
- Made for
- Adults (0 months and older)
Details
- Units affected
- 2,961 bottles
- Illnesses reported
- None reported
- Manufactured in
- 5187 Camino Ruiz, N/A, Camarillo, CA, United States
- Classification
- Class II
- Recall number
- D-0587-2026
In the FDA's words
- Description
- 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. 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. Lots: GS065128, GS065844, GS066695, GS067432, GS067993, expires: 01/31/2027. Distribution: Within the U.S Market. Affected quantity: 2,961 bottles
- 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.
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