Diabetes drug recalled over excess levels of cancer-causing agent
Heads-up, consumers: A diabetes drug is being recalled because the drug contains excess amounts of a carcinogenic agent, the US Food and Drug Administration (FDA) announced this week.
Marksans Pharma Limited, a pharmaceutical company in India, announced an expanded recall of its metformin hydrochloride prolonged release tablets, a drug that helps people with type 2 diabetes lower their blood sugar levels. The recall, which was originally announced in June, was expanded to include an additional 76 unexpired lots of the medication on Monday.
"Marksans performed N-nitrosodimethylamine (NDMA) testing on unexpired identified marketed lots and found that NDMA levels in some lots exceeded the Acceptable Daily Intake Limit (ADI) of 96 ng / day lots are being recalled," said the FDA in announcing the recall.
NDMA is a "probable human carcinogen," which means that the FDA says it is a substance that can lead to cancer.
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“NDMA is a known pollution in water and food, including meat, dairy products and vegetables. Marksans Pharma Limited has received no reports of adverse events related to this recall, "said the FDA.
The recall affects metformin tablets between 500 mg and 750 mg. The tablets were sold under the brand name Time-Cap Labs, Inc., according to the announcement.
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The following products were recalled:
Metformin hydrochloride prolonged-release tablets, USP 500 mg:
90 counts: 49483-623-09
100 counts: 49483-623-01
500 counts: 49483-623-50
1000 counts: 49483-623-10
Metformin Hydrochloride Extended Release Tablets, USP 750 mg:
100 counts: 49483-624-01
The 500 mg tablets are embossed with “101” on one side and plain on the other. The 750 mg tablets are also embossed with “102” on one side and simple on the other according to the FDA.
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“Consumers who are taking these recalled amounts of Metformin ER tablets should continue to use them until a doctor or pharmacist gives them a replacement or alternative treatment option. It could be dangerous for patients with type 2 diabetes to stop taking metformin without talking to their doctor, ”warned the FDA. The consumer should contact their doctor or health care provider if they have any problems taking or using this medicine.
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