Zydus News: Zydus recalls over 55k bottles of generic drug in US

Drug agency Zydus Lifesciences is recalling over 55,000 bottles of generic remedy within the US market as a result of failed impurities specs. As per the newest enforcement report by the US Meals and Drug Administration (USFDA), Zydus Prescription drugs (USA) Inc is recalling 21,936 (30 depend) and 33,096 (100 depend) bottles of Colchicine tablets, that are used to deal with gout.

The affected lot is manufactured by Ahmedabad-based Zydus Lifesciences and marketed within the US by New Jersey-based Zydus Prescription drugs (USA) Inc.

USFDA stated the corporate is recalling the product as a result of “failed impurities/ degradation specs”.

An out-of-specification (OOS) consequence was noticed throughout launch testing of 1 lot for a associated substance, i.e. Beta-lumicolchicine, it added.

Zydus commenced the Class III recall on February 24 this 12 months.

As per the USFDA, a Class III recall is initiated in a “scenario through which use of, or publicity to, a violative product is just not more likely to trigger adversarial well being penalties”.

The US market is the most important marketplace for generic pharmaceutical merchandise. The market was estimated to be round USD 115.2 billion in 2019.