Biocon Recalls 3,665 Bottles Of Antifungal Drug In U.S. For Failed Degradation Specifications
The lot has been manufactured by Biocon Pharma and distributed in the U.S. by Iselin-based Biocon Pharma Inc.
Biotechnology major Biocon is recalling 3,665 bottles of antifungal medication from the U.S. market for "failed degradation specifications," according to the U.S. Food and Drug Administration.
In its latest Enforcement Report, the U.S. 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.
The USFDA noted that 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 U.S. by Iselin-based Biocon Pharma Inc., it added.
Biocon initiated the Class II nationwide (U.S.) recall on Jan. 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 Feb. 12, Biocon stated that the USFDA has issued a 'Complete Response Letter' 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 Jan. 7, the company stated that the USFDA had issued a CRL for Biocon Biologics' application for Insulin-R, a proposed biosimilar for diabetes treatment.
