Sun Pharma's subsidiary Taro recalls warfarin
Sun Pharma's American subsidiary Taro has recalled its leading blood clot drug Warfarin Sodium from the market after the USFDA found that the product did not meet its quality norms. This is the third recall for Sun Pharma. The recall was class II of the FDA recall guidelines which is defined as a situation in which the use of, or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.Sun Pharmaceutical's manufacturing facility in Karkhadi, Gujarat had received a warning letter in May from the US FDA after investigators identified violations of current good manufacturing practices and regulations for finished pharmaceuticals.
In July, Sun Pharma recalled 40,000 bottles of Venlafaxine Hydrochloride extended-release tablets, Gemcitabine and Metformin from the US market. This was followed by the recall of 400,000 units of its antibacterial drug Cephalexin for not following good manufacturing practices.