Sun Pharma, Dr Reddy's Initiate Drug Recalls In US Market Over Manufacturing Issues: USFDA

Sun Pharma and Dr Reddy's Laboratories are recalling products in the American market due to manufacturing issues, the US Food and Drug Administration has said.

In its latest Enforcement Report, the US health regulator stated that a US-based unit of Sun Pharma is recalling 35,069 bottles of medication used to treat high pressure inside the eye due to glaucoma or other eye diseases.

New Jersey-based Sun Pharmaceutical Industries Inc is recalling the affected lot of Xelpros (latanoprost ophthalmic emulsion) due to 'out of specification for particulate matter test'.

The company initiated the voluntary Class III recall in the US on April 22 this year, the USFDA stated.

In a separate filing, the USFDA stated that a US-based arm of Dr Reddy's Laboratories is recalling 1,176 bottles of an immunosuppressant medication. Dr Reddy's Laboratories Inc is recalling the affected lot of Sirolimus Tablets due to 'Failed Impurities/Degradation Specifications', the USFDA said.

The company initiated the Class III recall on May 1, 2024.

As per the USFDA, a Class III recall is initiated in a 'situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences'.

India is the largest supplier of generic medicines with around 20% 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.

India has the highest number of USFDA-compliant companies with plants outside the US.