The US Food and Drug Administration (FDA) has issued an urgent recall for a cholesterol-lowering drug, warning of potential serious health consequences. The recall affects Niacin Extended-Release 1,000-milligram tablets, a Vitamin B supplement used to treat high cholesterol and triglycerides.
Recall Details
According to the FDA report released on Friday, 2,961 bottles of the medication have been recalled. The reason cited 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.
This indicates that tests on stored inventory within a year after manufacture showed the drug was releasing less active ingredient than intended at the 24-hour mark, potentially reducing its effectiveness.
Affected Lots
The FDA identified five lots of the drug with an expiration date of January 31, 2027. The lot numbers are: GS065128, GS065844, GS066695, GS067432, GS067993.
Patients can identify affected prescriptions by checking the following product details:
- Product: GSMS Incorporated, NIACIN EXTENDED-RELEASE TABLETS, USP 1,000 MG, 90 tablets
- Manufacturer: Kremers Urban Pharmaceuticals Inc., a subsidiary of Lannett, Inc., Seymour, IN 47274
- Packager: GSMS Incorporated, Camarillo, CA 93012
Risk Classification
The recalling company, Golden State Medical Supply Inc. of Camarillo, CA, voluntarily initiated the recall. The FDA has classified this event as a Class II risk level, meaning that use of or exposure to the violative product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse health consequences is remote.
Recommendations for Patients
Patients who have been prescribed Niacin Extended-Release are advised to contact their prescribing doctor or dispensing pharmacist immediately for a replacement. Do not stop taking the medication without consulting a healthcare professional.
