The US Food and Drug Administration (FDA) on Friday issued a report that 2,961 bottles of a 1,000-milligram Vitamin B supplement used to lower high cholesterol and triglycerides had been recalled.
The FDA listed the reason for recall of the Niacin Extended-Release brand as: 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.
This could mean 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.
The FDA said five lots of the drug show an expiration date of 1/31/2027, these being: GS065128, GS065844, GS066695, GS067432, GS067993.
You can identify whether your prescription is affected by using the following details:
The report says the recalling company, Golden State Medical Supply Inc. of Camarillo, CA, voluntarily recalled the drug.
The FDA has given this event a Class II risk level, indicating “a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
It is advisable to contact your prescribing doctor or dispensing pharmacist right away for a replacement, and before stopping consumption of the drug.
