Metformin is prescribed by doctors for the management of type 2 diabetes. It is sold under several different brand names: Fortamet, Glucophage, Glumetza, and Riomet. (EverydayHealth.com)
Marksans Pharma Limited of India has expanded its recall from June 5, 2020 to include 76 additional lots of unexpired Metformin Hydrochloride Extended-Release Tablets in 500 mg and 750 mg packages, sold under the name Time-Cap Labs, Inc.
Although there have been no adverse effects reported by patients taking the medication, the company recalled the additional lots after testing showed Nitrosodimethylamine (NDMA) “content in some lots exceeded the acceptable daily intake limit.” (TheState.com) Marksans Pharma Limited pulled the lots “out of an abundance of caution.” The actual recall, along with specifics on the 76 additional lots that are now being recalled can be found on the FDA’s website.
According to The Agency for Toxic Substances & Disease Registry, NDMA “is very harmful to the liver of animals and humans…Although there are no reports of NMDA causing cancer in humans, it is reasonable to expect that exposure to NDMA by eating, drinking, or breathing could cause cancer in humans.” Tests done on rats and mice showed when exposed to low levels of NMDA for periods of more than several weeks, liver and lung cancer occurred, as well as noncancerous liver damage.
As of October 16, 2020, eight drug companies: Amneal, Apotex, Bayshore, Granules, Lupin, Marksans, Sun Pharmaceuticals, and Teva have recalled their metformin-ER, according to the U.S. Food and Drug Administration (FDA).
If you are currently taking metformin, do not stop taking it without speaking to your doctor first. Doing so could cause your blood sugar to dip or spike, which could be dangerous. Instead, check the prescription bottle to find the exact type of metformin prescribed. Then check the FDA list of all metformin recalls to date to see if yours is on the recall list. If your medication is on the recall list, contact the doctor who prescribed it and ask what you need to do. If your medication is not on the recall list, continue to check the list of recalled metformin on the FDA’s website to make sure your medication is not recalled. If you’re not sure whether or not the metformin you’re taking has been recalled, call the physician who prescribed it.
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