Zydus recalls over 55k units of generic drug in US
- New Delhi: Drug firm Zydus Lifesciences is recalling over 55,000 bottles of generic medica- tion 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 tab- lets, 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. USFDA said the company is re- calling the product due to "failed impurities/ degradation specifi- cations".
- An out-of-specification (OOS) result was observed during re- lease testing of one lot for a relat- ed substance, i.e. Beta-lumicol- chicine, it added.
- Zydus commenced the Class III recall on February 24 this year. As per the USFDA, a Class III re- call is initiated in a "situation in which use of, or exposure to, aviolative product is not likely to cause adverse health consequences".
- The US market is the largest market for generic pharmaceutical products. The market was estimated to be around $115.2 billion in 2019.