Drug firm Zydus Lifesciences is reviewing north of 55,000 containers of conventional prescription in the US market because of bombed contaminations particulars.
According to the most recent requirement report by the US Food and Medication Organization (USFDA), Zydus Drugs (USA) Inc is reviewing 21,936 (30 count) and 33,096 (100 count) jugs of Colchicine tablets, which are utilized to treat gout.
Zydus Lifesciences, based in Ahmedabad, produces the affected lot and sells it in the United States through Zydus Pharmaceuticals (USA) Inc., based in New Jersey. According to the US Food and Drug Administration (FDA), the company is recalling the product because of some failed impurities in the US.
It added that one lot of release testing for a related substance, Beta-lumicolchicine, produced an out-of-specification (OOS) result. This year, Zydus began the Class III recall on February 24, 2023.
According to the US Food and Drug Administration (FDA), a Class III recall is initiated when the use of or exposure to a violative product is not likely to result in adverse health effects. The US market is the biggest market for conventional drug items. In 2019, the market was estimated to be worth about USD 115.2 billion.