After it was found to contain a carcinogen, a popular diabetes drug was withdrawn from the market.
The US Food and Drug Administration decided, this week, to withdraw the drug “metformin hydrochloride” for treating diabetes, because it contains excessive levels of a carcinogen.
The drug’s manufacturer, Marksans Pharma Limited, has expanded the recall that was initially announced in June, to now include 76 additional unexpired quantities of the drug.
The recall is marketed under the brand name Time-Cap Labs, Inc. It contains an unacceptably high level of N-Nitrosodimethylamine, which is considered a possible human carcinogen.
In its announcement, the Food and Drug Administration stated that the company producing the drug “conducted a N-Nitrosodimethylamine (NDMA) test for parts limited to the market, not expired, and noted that the NDMA content in some parts exceeds the acceptable daily limit (of 96 ng / day”).
The decision to withdraw applies to metformin tablets between 500 mg and 750 mg, according to the announcement.
The Food and Drug Administration advised users of the drug not to stop it, until their doctors consulted to provide an alternative option.
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