At the top, consumers: A diabetic drug is faced because the drug contains excess levels of a cancer-causing agent, the US Food and Drug Administration (FDA) announced this week.
Marksons Pharma Ltd., a pharmaceutical company in India, announced the recall of its metformin hydrochloride extended-release tablets, a drug used to help people who suffer from type 2 diabetes who are suffering from their blood Reduce sugar levels. The recall, which was initially announced in June, was expanded on Monday to include 76 additional drugs.
“Marcus tested N-Nitrosodimethylamine (NDMA), which did a lot of unrecognized marketing and saw that some had NDMA content higher than the allowable Daily Intake Limit (ADI) of 96ng / day, therefore, caution. Abundantly, additional 76. Many are being recalled.
NDMA is a “potential human carcinogen”, meaning it is a substance that can cause cancer according to the FDA.
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“NDMA is an environmental pollution found in water and food including meats, dairy products and vegetables. Marksons Pharma Ltd has not received any reports of adverse events related to this recall, ”the FDA said.
Recall affects metformin tablets between 500 mg and 750 mg. According to the announcement, the tablet was sold under the brand name Time-Cap Labs, Inc.
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The following products have been recalled:
Metformin hydrochloride extended-release tablet, usp 500mg:
90 count: 49483-623-09
100 counts: 49483-623-01
500 count: 49483-623-50
Count of 1000: 49483-623-10
Metformin hydrochloride extended-release tablet, usp 750mg:
100 counts: 49483-624-01
500 mg tablets are debossed with “101” on one side and plain on the other side. Meanwhile, the 750 mg tablets are also debossed with “102” on one side and on the other, are plain according to the FDA.
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“Consumers who take these recalled products of metformin ER tablets very rarely should continue this until doctors or pharmacists give them the option of replacement or different treatments. It can be dangerous for patients with type 2 diabetes to stop taking their metformin without talking to their healthcare professional. Consumers should “contact their physician or healthcare provider if they have a problem that may be related to taking or using this pharmaceutical product.”