Five other manufacturers have recalled the popular diabetes medication due to the presence of a the carcinogenic ingredient.
Not long after five manufacturers recalled numerous lots of metformin for type 2 diabetes due to N-nitrosodimethylamine (NDMA) levels above the acceptable daily limit, another manufacturer is recalling certain lots of metformin.
Granules Pharmaceuticals is voluntarily recalling 12 lots of its Metformin Hydrochloride Extended-Release Tablets USP, 750 mg, 100-count, and 500 count bottles within expiry to the consumer level due to the detection of NDMA.
Related: Major metformin recalls underway
“Granules’ test results showed NDMA levels above the FDA acceptable limit in 1 out of the twelve 12 batches distributed to the U.S. market,” the pharma maker said in a press release. However, all other batches continue to remain within the specifications, the manufacturer said.
In early June, five manufacturers recalled their extended-release metformin tablets due to high levels of NDMA.
Granules said it 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,” the company said.
Granules 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 the recall.
The lots were distributed nationwide to distributors and retailers.