FDA recommends that health care professionals continue to prescribe metformin when clinically appropriate; FDA testing has not shown NDMA in immediate release (IR) metformin products (the most commonly prescribed type of metformin). These methods should be validated by the user if the resulting data are used to support a required quality assessment of the API or drug product, or if the results are used in a regulatory submission. The FDA announced the previous recall, involving Marksans Pharma Limited and Sun Pharmaceutical Industries products, on Oct. 5. Update [6/11/2020] FDA is alerting patients and health care professionals to five companies’ voluntary recalls of certain extended release (ER) metformin drugs. The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. [2/3/2020] The U.S. Food and Drug Administration posted laboratory results showing N- Nitrosodimethylamine (NDMA) levels in some metformin products approved in the U.S. FDA has determined that the levels of NDMA in metformin products tested range from not detectable to low levels. In summary, the agency found the private laboratory method to be inappropriate for quantifying NDMA in metformin drug products due to presumptive overestimation of NDMA caused by the presence of a substance that interfered with the testing results. Out of an abundance of caution, the company is recalling all batches of Metformin Hydrochloride Extended-Release Tablets USP, 500mg and 1000mg in the US. The agency’s testing has not shown NDMA in immediate release (IR) metformin products (the most commonly prescribed type of metformin). This paper assesses the cause for the discrepancy between the NDMA values FDA found in its testing of metformin drug products and the values a private laboratory reported. ISSUE: FDA is requiring labeling changes regarding the recommendations for metformin -containing medicines for diabetes to expand metformin’s use in certain patients with reduced kidney function. Update [10/5/2020] FDA is alerting patients and health care professionals to two voluntary recalls of extended release (ER) metformin by Marksans Pharma and Sun Pharmaceutical Industries. The FDA announced that it had asked five pharmaceutical firms to voluntarily recall products containing extended-release formulations of metformin hydrochloride, a drug frequently prescribed to patients with type 2 diabetes to manage blood glucose levels.. The site is secure. The FDA also stresses there are many other additional manufacturers that supply metformin ER products to much of the US market, and they are not being asked to recall their products. The recalls began this summer, when FDA found elevated NDMA levels in products from five different manufacturers. Patients taking recalled ER metformin should continue taking it until a doctor or pharmacist gives them a replacement or a different treatment option. By Ed Silverman @Pharmalot. On May 28, 2020 the FDA issued a press release announcing they contacted five manufactures of the diabetic medication, Metformin and recommended they voluntarily recall the drug due to contamination.. The .gov means it’s official.Federal government websites often end in .gov or .mil. Update [7/13/2020] FDA is alerting patients and health care professionals to several voluntary recalls of extended release (ER) metformin by the companies listed below. In a fifth recall for the diabetes drug Metformin, Lupin Pharmaceuticals has recalled Metformin Hydrochloride Extended-Release Tablets because they may contain N … Overall, FDA observed that in orthogonal tests, the levels of NDMA, when present, were generally lower than reported by the private laboratory. 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