Bayshore Pharmaceuticals issues recall of some metformin hydrochloride ER tablets USP, 500 mg and 750 mg

Bayshore Pharmaceuticals is voluntarily recalling one lot of Metformin Hydrochloride Extended-Release Tablets USP, 500 mg, 1000 count bottles and one lot of Metformin Hydrochloride Extended-Release Tablets USP, 750 mg, 100 count bottles within expiry to the consumer level due to the detection of N-Nitrosodimethylamine (NDMA) levels above the Acceptable Daily Intake (ADI) limit. This product was manufactured by Beximco Pharmaceuticals Limited, Dhaka, Bangladesh in June 2019, for U.S. distribution by Bayshore. Bayshore was notified by FDA that one lot (Lot number 18657) of Metformin Hydrochloride Extended-Release Tablets, USP 750 mg was tested and showed results for NDMA levels in excess of the ADI limit and recommended recall of the one tested lot. Bayshore has agreed to recall this lot, and out of an abundance of caution, the company has tested samples from eight lots of Metformin Hydrochloride Extended-Release Tablets manufactured using same API lot of the failed lot.