NDMA in ER Metformin: Several companies voluntarily recalling the diabetes medicine

[FDA Update, July 13, 2020] – FDA is alerting patients and health care professionals to several voluntary recalls of extended-release (ER) metformin due to possible contamination with nitrosodimethylamine (NDMA) above the acceptable intake limit.

Note that FDA testing has not shown NDMA in immediate-release (IR) metformin products (the most commonly prescribed type of metformin).

IMPORTANT LINKS

Search database of recalled metformin products: https://www.fda.gov/drugs/drug-safety-and-availability/search-list-recalled-metformin-products

QA on NDMA impurities in metformin products: https://www.fda.gov/drugs/drug-safety-and-availability/questions-and-answers-ndma-impurities-metformin-products

Information about nitrosamine impurities in medications: https://www.fda.gov/drugs/drug-safety-and-availability/information-about-nitrosamine-impurities-medications

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