Recall

Bayshore Pharmaceuticals, LLC, Short Hills, NJ is voluntarily recalling one (1) lot of Metformin Hydrochloride Extended-Release Tablets USP, 500 mg, 1000 count bottles and one (1) 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 Limit. This product was manufactured by Beximco Pharmaceuticals Limited, Dhaka, Bangladesh in June 2019, for U.S. distribution by Bayshore.
Bayshore was notified by the U.S. Food and Drug Administration (US FDA) that one lot (Lot number 18657) of Metformin Hydrochloride Extended-Release Tablets, USP 750 mg was tested and showed results for N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit (ADI) 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 (8) lots of Metformin Hydrochloride Extended-Release Tablets manufactured using same API lot of the failed lot. Out of eight (8) lots, one lot (Lot number 18657) of Metformin Hydrochloride Extended-Release Tablets, USP 750 mg and one lot (Lot number 18641) of Metformin
Hydrochloride Extended-Release Tablets, USP 500 mg have showed N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit (ADI). Hence, Bayshore has decided to recall the two lots (Lot number 18641 and 18657). To date, neither Bayshore nor Beximco have received any reports of adverse events related to use of the product.

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