The recalled drugs are marketed as “extended-release tablets” under the brand name Time-Cap Labs, Inc.
The drug helps lower blood sugar levels in people with type 2 diabetes.
But the recalled product contained an unacceptable level of N-Nitrosodimethylamine, which is considered a probable human carcinogen.
“Marksans carried out tests with N-Nitrosodimethylamine (NDMA) on marketed batches identified as unexpired and observed that the NDMA content of certain batches exceeds the acceptable daily intake limit (ADI) of 96 ng / day”, the FDA pointed out in its announcement.
“Consequently, as a precaution, 76 additional lots are being recalled.
The booster applies to metformin tablets between 500 mg and 750 mg.
The 500 mg tablets are debossed with “101” on one side; the 750 mg tablets are debossed with “102” on one side, the agency said.
The FDA advises users to continue taking the recalled tablets until a healthcare practitioner offers a replacement or alternative treatment option.
“It could be dangerous for patients with type 2 diabetes to stop taking their metformin without first talking to their healthcare professional,” the FDA said in a statement.
Consumers “should contact their doctor or health care provider if they have encountered any problems that may be related to taking or using this medicine.”