Zydus Pharmaceuticals announced a voluntary recall of one lot of Warfarin 2mg Tablets because they have been found to be oversized in a product complaint.
The affected product has Lot #MM5767 and NDC # 6838205310 with an expiration date June 2014. It is packaged in HDPE Bottle of 1000’s, which may have been dispensed to patients in smaller bottles. The distribution dates range from November to December 2012.
An increased pharmacological effect of warfarin can result after ingesting a greater than intended dose. This puts patients at a greater risk of bleeding, and it could potentially be fatal for some. The bleeding risk is increased if overdosing is repeated continuously each day.
Zydus has notified its direct account customers by sending the recall notification letter by FedEx next day air service and is working with customers to arrange for product return.
Warfarin is a coumarin anticoagulant used as prophylaxis and treatment of venous thrombosis and its extension, pulmonary embolism (PE), prophylaxis and treatment of thromboembolic complications associated with atrial fibrillation (AF) and/or cardiac valve replacement and reduction in the risk of death, recurrent myocardial infarction (MI), and thromboembolic events such as stroke or systemic embolization after myocardial infarction.
For more information call (800) 967-5952 or visit ZydusUSA.com.