The diabetes drug Metformin hydrochloride has been withdrawn because it contains excess levels of a carcinogen, the U.S. Food and Drug Administration announced this week.
The drug’s manufacturer, Marksans Pharma Limited, has expanded a recall initially announced in June to now include an additional 76 unexpired batches of the drug.
The recalled drugs are marketed as “extended-release tablets” under the brand name Time-Cap Labs, Inc.
The drug helps lower the blood glucose levels of those with type 2 diabetes.
But the recalled product contained an unacceptably high level of N-nitrosodimethylamine, which is considered a probable human carcinogen.
“Marksans performed tests for N-nitrosodimethylamine (NDMA) on unexpired identified marketed batches and noted that the NDMA content in some batches exceeds the daily acceptable intake limit (ADI) of 96 ng / day,”
“Therefore, for an abundance of caution, another 76 lots are recalled.”
The recall applies to metformin tablets between 500 mg and 750 mg.
The 500 mg tablets are marked “101” on one side; the 750-mg tablets are marked “102” on one side, the agency said.
The FDA advises users to continue taking the recalled tablets until a doctor provides a replacement or alternative treatment option.
“It may be dangerous for patients with type 2 diabetes to stop taking metformin without first talking to their doctor,” the FDA said in a statement.
Consumers “should contact their doctor or healthcare professional if they have encountered any problems that may be related to taking or using this medicine”.