FDC recalls more than 60000 bottles of glaucoma medication in US

Written By :  Ruchika Sharma
Medically Reviewed By :  Dr. Kamal Kant Kohli
Published On 2025-05-10 07:00 GMT   |   Update On 2025-05-10 07:00 GMT

Mumbai: Mumbai-headquartered drug firm FDC Ltd is recalling 60,428 bottles of Timolol Maleate Ophthalmic Solution in the US market over manufacturing issue, as per the US Food and Drug Administration's latest Enforcement Report.

Timolol Maleate Ophthalmic Solution is used for the treatment of glaucoma, a condition that causes damage to the optic nerve due to increased pressure in the eye.

"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.

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Read also: Sun Pharma, Zydus and Glenmark recall various products in US over manufacturing issues

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

This is not the first time FDC has faced such an issue. Last year, Medical Dialogues reported that the company had recalled 155,232 bottles of the same eye medication from the US market.

Read also: Dr Reddy's Labs, FDC recall generic medications in US over manufacturing issues

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