Zydus Lifesciences recalls over 55000 bottles of gout drug Colchicine in US
The affected lot is manufactured by Ahmedabad-based Zydus Lifesciences and marketed in the US by New Jersey-based Zydus Pharmaceuticals (USA) Inc.
Ahmedabad: 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.
Gout is a form of inflammatory arthritis characterized by recurrent attacks of a tender, hot, red, and swollen joint, caused by the deposition of needle-like crystals of uric acid known as monosodium urate crystals.
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 $115.2 billion in 2019.
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Zydus Lifesciences Limited, Formerly known as Cadila Healthcare Limited, is an Indian Pharmaceutical company headquartered in Ahmedabad. The company was founded in the year 1952 by Mr. Ramanbhai B. Patel (late), a first-generation entrepreneur and a doyen in the field of Indian Pharmaceuticals. It is primarily engaged in the manufacture of generic drugs.
