Diabetes medicine metformin recalled due to high level of anti-cancer agent

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The diabetes drug metformin hydrochloride has been recalled because it contains excessive levels of a carcinogen, the US Food and Drug Administration said this week.The drug’s maker, Marksans Pharma Limited, has expanded a recall originally announced in June to now include an additional 76 unexpired lots of the drug.

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.”

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