Some of the tablets are oversized, containing a greater-than-intended dose
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Zydus Pharmaceuticals USA is recalling one lot of warfarin 2 mg tablets, Lot #MM5767, expiration date June 2014 to the retail level.
Four tablets have been found to be oversized in one product complaint. Ingestion of a greater than intended dose of warfarin could lead to an increased pharmacological effect and, 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 could be fatal. The risk of bleeding is increased if overdosing is repeated continuously on a daily basis.
There have been no reports of adverse events or any additional product complaint related to this lot to date.
The product is packaged in HDPE Bottle of 1000's count, which may have been dispensed to patients in smaller bottles. It can be identified by its NDC #6838205310. The product was distributed nationwide in the United States to wholesalers/distributors, retailers and mail order providers, from November 2012 to December 2012.
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.
Anyone with an existing inventory of this particular lot should stop use and distribution, quarantine the recalled lots immediately and call INMAR at 1-800-967-5952 between the hours of 7 a.m. to 4 p.m. CST, Monday through Friday, to arrange for their return. Patients who have tablets of this lot should make sure all the tablets are of the same size and, if unsure, should consult their dispensing pharmacy.
