FDC is recalling 60,428 bottles of Timolol Maleate Ophthalmic Solution, used to treat glaucoma, in the US market due to manufacturing issue. The company is recalling the affected lot due to ‘Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle’. The drugmaker initiated the Class II nationwide (US) recall on April 18, 2025.
As per the USFDA, a Class II recall is initiated in a situation in which the 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.
