Zydus Lifesciences’ subsidiary -- Zydus Pharmaceuticals (USA) Inc. is recalling over 55,000 bottles of generic medication in the US market due to failed impurities specifications. As per the latest enforcement report by the US Food and Drug Administration (USFDA), Zydus Pharmaceuticals (USA) Inc is recalling 21,936 (30 count) and 33,096 (100 count) bottles of Colchicine tablets, which are used to treat gout.
The affected lot is manufactured by Ahmedabad-based Zydus Lifesciences and marketed in the US by New Jersey-based Zydus Pharmaceuticals (USA) Inc. The company is recalling the product due to ‘failed impurities/ degradation specifications’. Zydus commenced the Class III recall on February 24 this year. As per the USFDA, a Class III recall is initiated in a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Zydus Lifesciences (formerly known as Cadila Healthcare) is an India-based pharmaceutical company.
