Voluntary Recall of Metformin Hydrochloride Extended Release Tablets

Drug Recall, Safety Communications, Voluntary ADR reporting, ,

Metformin Hydrochloride is indicated as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus. N‑Nitrosodimethylamine (NDMA) is classified as a probable human carcinogen (a substance with potential to cause cancer) based on results from laboratory tests. With the release of alert of NDMA presence in Metformin…

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Presence of Nitrosamines (N-Nitrosodimethylamine) in Metformin Extended Release formulations

Drug Recall, Drug Safety Alert, Drug Safety Updates, , ,

Metformin is a prescription drug and a first line medication used to control high blood sugar in patients with type 2 diabetes. N-Nitrosodimethylamine is a probable human carcinogen which is not harmful when present within the permitted limits. Exposure to some level of nitrosamines is quite common, as these nitrosamines presence are common in water…

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