FDC is recalling 1,76,784 bottles of Timolol Maleate Ophthalmic Solution USP due to ‘Defective Container’. FDC is recalling products in the US. Patients are unable to get the solution out of the bottle as the spike of the cap is lodged in the nozzle of the product bottle. The company initiated the Class II recall on August 12 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.
FDC is among India’s leading fully integrated pharmaceutical companies.