Biotechnology major Biocon is recalling 3,665 bottles of antifungal medication in the US market for “failed degradation specifications”, according to the US Food and Drug Administration (USFDA).
In its latest Enforcement Report, the US health regulator said that the Bengaluru-based firm is recalling 3,665 bottles of Posaconazole Delayed-Release Tablets (100 mg, 60-count bottle), used to treat serious fungal infections like invasive aspergillosis.
USFDA noted that the New Jersey-based Biocon Pharma Inc is recalling the affected lot due to “Failed Impurities/Degradation Specifications: High Out Of Specification degradation results.” The lot has been manufactured by Biocon Pharma and distributed in the US by Iselin-based Biocon Pharma Inc, it added.
Biocon initiated the Class II nationwide (US) recall on January 31, this year.
As per the USFDA, a class II recall is initiated in a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
On February 12, Biocon stated that the USFDA has issued a Complete Response Letter (CRL) for the biologics licence application filed for Bevacizumab by its partner Viatris.
The USFDA issues a CRL to convey to a company that its initial review of an application is complete and it cannot approve the application in its present form.
Earlier on January 7, the company had stated that the USFDA has issued a complete response letter for Biocon Biologics' application for Insulin-R, a proposed biosimilar for diabetes treatment.
(This story has not been edited by NDTV staff and is auto-generated from a syndicated feed.)
Featured Video Of The Day
Cipla, Glenmark Recall Asthma Drugs Made In Indore From US Market Centre Gives Sanction To Prosecute Joint Drugs Controller In Bribery Case Serum Institute To Double Investment In Biocon's Unit To $300 Million Trainee IAS Officer Puja Khedkar Recalled To Academy, Training Put On Hold Under-Fire Trainee IAS Officer Accuses Pune Collector Of Harassment "No Defamatory Remarks Against Governor": High Court To Mamata Banerjee Study Abroad: Top 10 Affordable Universities In The UK Man Sets Mother On Fire Inside UP Police Station, Films Her Byju's Faces Insolvency Proceedings For Failure To Pay BCCI Rs 158.9 Crore Track Latest News Live on NDTV.com and get news updates from India and around the world.