Voluntary Recall Announced by Apotex Corp. Because of NDMA Found in Metformin Samples
WASHINGTON, D.C. — The U.S. Food and Drug Administration, most often referred to as the FDA, announced a recall commenced by Apotex Corp for its metformin hydrochloride extended-release 500-milligram tablets after the company found N-nitrosodimethylamine or MDMA in the certain samples. NDMA is known as a human carcinogen. Even though The FDA permits consumption of MDMA within certain daily limits, there is the potential to develop cancer if consumption of MDMA exceeds recommended limits, according to an Apotex Corporation Company announcement published by the FDA. The FDA’s publication indicates that the recall extends to users who purchased the recall drugs at the consumer level. Apotex Corp. did not report any adverse reactions or injuries caused by the recall medication.
Apotex Corporation received notification from the FDA that one lot of the company’s metformin hydrochloride extended-release tablets returned a positive result for NDMA. The FDA said at the levels of MDMA in the tested lot exceed the acceptable daily intake limit. As a result, the FDA recommended it recall. Apotex agreed to the recall, out of an abundance of caution, according to the FDA statement. As a result of this recall, April text will remove the remainder of the product from store shelves. April text previously recalled the product in February of 2019, and as a result of that recall campaign, a small amount of the recalled medication remained available for sale to the consumer.
Laboratory tests indicate that MDMA a human carcinogen. As a result, federal agencies like the FDA monitor the daily intake of products that contain NDMA. NDMA is consumed daily through the consumption of me, dairy, and vegetables in the U.S.
Metformin is a drug designed to help patients suffering from type 2 diabetes mellitus to control blood sugar. Metformin is most successful when used in conjunction with proper diet and exercise. The FDA cautions that patients should not stop taking the medication until they speak with the prescribing physician, and substitute therapy is prescribed. At that point, the recalled prescription may be returned to be prescribing pharmacy.
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