The Harvard Drug Group is recalling 1,906 cartons of Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, which is a prescription medication used to manage blood sugar in patients with type 2 diabetes. This recall was initiated because the product, manufactured by Apotex, Inc., may contain an impurity called Nitrosodimethylamine (NDMA) at levels that exceed the safety limits established by the FDA. The affected products were distributed nationwide in 100-tablet unit dose cartons under the Major Pharmaceuticals brand name. Consumers should contact their healthcare provider or pharmacist to discuss alternative treatments and should not stop taking the medication without a replacement.
NDMA is classified as a probable human carcinogen, meaning long-term exposure to levels above the acceptable daily intake may increase the risk of developing cancer. While no immediate injuries or adverse events have been reported for this specific lot, the concentration of the impurity was found to be higher than what is considered safe for daily consumption.
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If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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