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Zydus recalls over 55k bottles of generic drug used to treat gout in US

Drug firm Zydus Lifesciences is recalling over 55,000 bottles of generic medication in the US market due to failed impurities specifications

Cadila Healthcare changes name to Zydus Lifesciences Limited

Press Trust of India New Delhi

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Drug firm Zydus Lifesciences 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.
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.

(Only the headline and picture of this report may have been reworked by the Business Standard staff; the rest of the content is auto-generated from a syndicated feed.)

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First Published: Mar 26 2023 | 12:48 PM IST

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