Zydus Lifesciences: Zydus recalls over 55k bottles of generic drug in US, Health News, ET HealthWorld
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.
USFDA said the company is recalling the product due to "failed impurities/ degradation specifications".
An out-of-specification (OOS) 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 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".
The US market is the largest market for generic pharmaceutical products. The market was estimated to be around USD 115.2 billion in 2019.
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Sunday, March 26, 2023 at 7:40 am