Dr Reddy's, FDC recall products in US for manufacturing issues

Dr Reddy's Laboratories and FDC Ltd are recalling generic medications in the US market due to manufacturing issues, according to the US health regulator.

As per the latest Enforcement Report by Food and Drug Administration (USFDA), the US-based subsidiary of Dr Reddy's Laboratories is recalling multiple strengths of Morphine Sulfate extended-release tablets in the US.

The medication is used to relieve severe and persistent pain.

As per the USFDA, Princeton-based Dr Reddy's Laboratories Inc is recalling 2,040 bottles of 15 mg Morphine Sulfate extended-release tablets due to "Failed Impurities/Degradation Specification".

The drugmaker is also recalling another 532 100-count bottles of the medication in 30 mg strength for the same reason, USFDA stated.

Dr Reddy's initiated the Class II nationwide recall on October 22 this year.

USFDA said Mumbai-headquartred FDC Ltd 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 US health regulator stated.

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 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.

India is the largest supplier of generic medicines with around 20 per cent share in the global supply by manufacturing 60,000 different generic brands across 60 therapeutic categories.

The products manufactured in the country are shipped to over 200 countries around the globe, with Japan, Australia, West Europe, and the US as the main destinations.