A lot of warfarin 2 mg tablets is under recall for being oversized.
Zydus Pharmaceuticals USA reported that it received one product complaint of four oversized tablets. Ingesting oversized tablets could increase the risk of bleeding, which in a critical organ such as the central nervous system could be fatal. The risk increases with frequency of overdosing.
Zydus had no reports of adverse events.
The affected lot is Lot MM5767 with an expiration date June 2014. The product identifier is NDC 6838205310. It was distributed nationwide in the U.S. between November to December 2012.
Warfarin is prescribed to reduce the risk of stroke in patients with atrial fibrillation. It also is indicated as a prophylaxis and treatment of venous thrombosis and pulmonary embolism and as a prophylaxis and treatment of thromboembolic complications associated with cardiac valve replacement.
Patients with 2 mg tablets from the affected lot should discontinue use, and tablets should be quarantined and returned. Zydus said it is working with customers to arrange for returns.