Bayshore Pharmaceuticals issued a voluntary recall of 2 lots of its extended-release metformin products due to high levels of NDMA.
Officials with the FDA have issued a safety alert regarding Bayshore Pharmaceuticals’ voluntary recall of 2 lots of extended-release (ER) metformin tablets.
According to a company announcement, Bayshore Pharmaceuticals is recalling 1 lot of metformin hydrochloride ER tablets USP, 500 mg, 1000 count bottles and 1 lot of metformin hydrochloride ER tablets USP, 750 mg, 100 count bottles within expiry to the consumer level due to detection of unacceptable levels of N-Nitrosodimethylamine (NDMA).
Out of the abundance of caution, Bayshore said it had tested samples from 8 lots manufactured using the same active pharmaceutical ingredient of the failed lot. Out of the 8 lots, 1 lot (Lot number 18657) of 750 mg tablets and 1 lot (Lot number 18641) of 500 mg tablets have showed NDMA levels in excess of the Acceptable Daily Intake Limit.
In early February, the FDA posted the results of its laboratory analysis showing NDMA levels in some samples of the metformin products it tested. Overall, the levels of NDMA found in metformin ranged from “not detectable to low levels” at the time. However, recalls for ER metformin products began in May after the FDA reported it found elevated levels of NDMA in certain products.
To date, neither Bayshore nor Beximco, the company that manufactured the product, have received any reports of adverse events related to the use of the product.
The FDA published a recalled metformin list including details about metformin products that have been recalled. According to the FDA, its testing has not shown NDMA in immediate-release metformin products.
Bayshore Pharmaceuticals, LLC Issues Voluntary Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets USP, 500 mg and 750 mg Due to the Detection of N-Nitrosodimethylamine (NDMA) Impurity. Company Announcement. FDA; August 20, 2020. Accessed August 21, 2020. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/bayshore-pharmaceuticals-llc-issues-voluntary-nationwide-recall-metformin-hydrochloride-extended