Zydus Pharmaceuticals USA Inc, the US subsidiary of Zydus Cadila, is recalling one lot of blood thinner drug Warfarin in the US market after finding the tablet oversized.
Zydus is recalling Warfarin 2 mg Tablets, Lot No MM5767 with expiration date June 2014 since four tablets have been found to be oversized in one product complaint.
The US Food and Drug Administration said that taking a greater than intended dose of Warfarin, could lead patients more likely to develop bleeding as an adverse reaction and in some patients that bleeding into a critical organ could be fatal.
The risk of bleeding is increased if overdosing is repeated continuously on a daily basis.
Zydus said that it has not received any reports of adverse events or any additional product complaint related to this lot to date.
Warfarin is used as prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism, prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation and / or cardiac valve replacement and reduction in the risk of death, recurrent myocardial infarction, and thromboembolic events such as stroke or systemic embolization after myocardial infarction.
The drug was distributed in the US to wholesalers/distributors, retailers and mail order providers, in November-December 2012.
Zydus said that it has notified its direct account customers and said that anyone with an existing inventory of this particular Lot should stop use and distribution.