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.
(Except for the headline, this story has not been edited by NDTV staff and is published from a syndicated feed.)
Featured Video Of The Day
PM Modi Pays Tribute To Mahatma Gandhi In Guyana
Glenmark Pharmaceuticals Recalls 1,200 Bottles Of "Subpotent" Hypertension Drug In US Zydus Cadila's ZyCoV-D To Be Introduced In Covid Vaccine Drive Shortly: Centre Talks On To Make Covid DNA Vaccine Part Of Inoculation Drive: Centre "Thousand Times Better...": Delhi Lt Governor's Surprise For AAP's Atishi "World War 3 Has Begun": Ukraine Ex-Military Commander Amid Russia Conflict UK To Arrest Netanyahu If He Visits, "Will Comply" With World Court Order US Court Tosses Case Involving Securities Fraud Suit Against Facebook AIIMS, IIT Delhi, And UCL Collaborate To Advance Healthcare Innovation Hospitals Have Only 2 Days Worth Of Fuel Left, Says Gaza Health Ministry Track Latest News Live on NDTV.com and get news updates from India and around the world.