The diabetes drug metformin hydrochloride has been recalled because it contains higher levels of the carcinogenic agent, U.S. The Food and Drug Administration made the announcement this week.
The manufacturer of the drug, Marksons Pharma Ltd, has extended the recall announced in early June, now adding an additional 76 unexpected drugs.
Returned Drug Sales Time-Cap Labs, Inc. Under the brand name “extended-release tablets”.
It helps lower blood glucose levels in people with type 2 diabetes.
But the previous product has an unacceptably high level of N-nitrosodimethylamine, which is considered a potential human carcinogen.
The FDA stated in its announcement, “Marks were tested for N-nitrosodimethylamine (NDMA) in identified marketing lots and observed that the NDMA levels in some lots exceeded the acceptable daily intake limit of 96 engines / day (AD).
“So, with great caution, extra lots 76 lots are being recalled.”
The recall is applied to metformin tablets between 500 mg and 750 mg.
500 mg tablets are dibbed with “101” on one side; The 750 mg tablets are debugged with “102” on one side, the agency said.
The FDA advises users to continue taking withdrawal pills until they are offered a medical professional replacement or alternative treatment option.
“It can be dangerous for patients with type 2 diabetes to stop taking their metformin without first talking to their health care professional,” the FDA said in a statement.
Consumers should “consult their physician or healthcare provider if they experience any problems related to taking or using this drug product.”
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