Granules India’s wholly owned subsidiary -- Granules Pharmaceuticals Inc (GPI) is voluntarily recalling 12 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 1 out of the 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 12 of the distributed lots within expiry of Metformin Hydrochloride Extended-Release Tablets USP, 750 mg from the market.
Granules India is manufacturer and supplier of pharmaceutical products. Its products include active pharmaceutical ingredients (API) like tablets, caplets, rapid release, pharmaceutical, formulation intermediates (PFI) and Finished Dosages (FDs).
