Granules Pharmaceuticals, Inc, a wholly owned subsidiary of Granules India Limited, is voluntarily recalling twelve lots of metformin hydrochloride extended-release tablets USP, 750 mg, 100 and 500 count bottles within expiry to the consumer level due to the detection of N-nitrosodimethylamine (NDMA) levels above the acceptable daily intake limit.
Granules’ test results showed NDMA levels above the FDA acceptable limit in one out of the twelve (12) batches distributed to the US market. All other batches continue to remain within the specifications. Out of abundance of caution Granules Pharmaceuticals, Inc. has decided to voluntarily recall all twelve (12) of the distributed lots within expiry of metformin hydrochloride extended-release tablets USP, 750 mg from the market.
Granules Pharmaceuticals, Inc. has not received any reports of adverse events that have been confirmed to be directly related to this recall as of the date of this letter.
Granules India’s metformin hydrochloride immediate-release tablets USP, 500 mg, 850 mg & 1,000 mg and metformin hydrochloride extended release tablets USP, 500 mg are not affected by this recall.
Granules’ metformin 750mg constituted about 0.3% of Granules India’s revenue for FY 20.
Metformin hydrochloride extended-release tablets USP, 750 mg are indicated as an adjunct to diet and exercise to improve blood sugar control in adults with type 2 diabetes mellitus.