FDC recalls over 60,000 bottles of ophthalmic solution in US

Drug firm FDC Ltd is recalling over 60,000 bottles of a generic medication, used to treat glaucoma, in the US market due to manufacturing issue, according to the US health regulator. As per the latest Enforcement Report by Food and Drug Administration (USFDA), the Mumbai-headquartered drug firm is recalling 60,428 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 USFDA said.

The drugmaker initiated the Class II nationwide (US) recall on April 18 this year.


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.

Shares of FDC on Friday ended 0.31 per cent up at Rs 430 apiece on the BSE.