FDC is recalling 1,55,232 bottles of Timolol Maleate ophthalmic solution in the US market. 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 company initiated the Class II recall on October 29, 2024. Timolol Maleate ophthalmic solution is used to treat high pressure inside the eye due to glaucoma.
As per the U.S. Food and Drug Administration (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.
