Granules Pharmaceuticals Inc. is voluntarily recalling 12 lots of diabetes drug Metformin Hydrochloride Extended-Release Tablets USP, 750 mg (100 and 500 count bottles) in the U.S. market after N-Nitrosodimethylamine (NDMA) levels were found to be above acceptable daily intake limit. The decision of the wholly owned subsidiary of Hyderabad-headquartered drugmaker Granules India to recall followed tests showing NDMA levels above the acceptable limit in one of the 12 batches distributed in U.S market.
A known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables, NDMA is classified as a probable human carcinogen.
Stating that all other batches of the drug continue to remain within the specifications, a release from the drugmaker said out of abundance caution Granules Pharmaceuticals Inc. has decided to voluntarily recall all twelve of the distributed lots within expiry from the market.
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Granules India’s Metformin Hydrochloride Immediate-Release Tablets USP, 500 mg, 850 mg and 1000 mg and Metformin Hydrochloride Extended Release Tablets USP, 500 mg are not affected by this recall. The release said Metformin 750 mg constituted about 0.3% of Granules India’s revenue for FY 20.
Last month, the USFDA had said that five companies had voluntarily recalled certain extended release (ER) Metformin drugs. It followed the US health regulator stating in May-end that laboratory tests had revealed levels of NDMA above acceptable intake limit in several lots of the extended-release (ER) formulation of Metformin.
“There are additional manufacturers of the Metformin ER formulation that supply a significant portion of the U.S. market and their products are not being recalled. The FDA is continuing to work closely with manufacturers to ensure appropriate testing,” the regulator had said.
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