Zydus Recalls Over 55,000 Bottles Of Generic Drug In U.S.
The FDA said the company is recalling the product due to "failed impurities/degradation specifications".
Drug firm Zydus Lifesciences is recalling over 55,000 bottles of generic medication in the U.S. market due to failed impurities specifications.
As per the latest enforcement report by the U.S. Food and Drug Administration, 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 U.S. by New Jersey-based Zydus Pharmaceuticals Inc.
USFDA said the company is recalling the product due to "failed impurities/ degradation specifications".
An out-of-specification result was observed during release testing of one lot for a related substance, i.e. Beta-lumicolchicine, it added.
Zydus commenced the Class III recall on Feb. 24 this year.
The U.S. market is the largest market for generic pharmaceutical products. The market was estimated to be around $115.2 billion in 2019.