Zydus Pharmaceuticals Inc., a subsidiary of Zydus Cadila, has started recalling a single lot of a blood thinner drug in the U.S. after receiving a complaint that some of the tablets were oversized.
The company is voluntarily recalling one lot of Warfarin 2 mg tablets, which is widely used to prevent blood clots, according to a U.S Food and Drug Adminstration notice.
Ingestion of a greater than intended dose of Warfarin could lead to bleeding as an adverse reaction, which, in certain cases, could be fatal.
“Zydus has not received any reports of adverse events related to this lot to date, but as a precautionary measure, it is recalling the lot from distribution.
“The company has notified its customers by sending a recall notification letter,” the notice said. The product in question was distributed in the United States to distributors, retailers and mail order providers from November to December 2012.