FDA Drug Safety Alert: Oversized Tablets Prompt Voluntary Recall

Warfarin 2 mg tablets (Lot #MM5767) have been voluntarily recalled by Zydus Pharmaceuticals USA Inc. due to a complaint of oversized tablets. “Ingestion of a greater than intended dose of Warfarin, could lead to an increased pharmacological effect of warfarin,” according to the FDA’s drug safety alert. “As a result, patients would be more likely to develop bleeding as an adverse reaction and in some patients that bleeding into a critical organ (mostly the central nervous system) could be fatal.” Read the complete FDA alert.

Clinical Topics: Anticoagulation Management

Keywords: Hemorrhage, Nervous System, Tablets, Warfarin, United States Food and Drug Administration


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