Latest News | Sun Pharma, Dr Reddy's Recall Drugs in US Market: USFDA
Get latest articles and stories on Latest News at LatestLY. Sun Pharma and Dr Reddy's Laboratories are recalling products in the American market due to manufacturing issues, the US Food and Drug Administration (USFDA) has said.
New Delhi, May 30 (PTI) Sun Pharma and Dr Reddy's Laboratories are recalling products in the American market due to manufacturing issues, the US Food and Drug Administration (USFDA) 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.
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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 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.
India has the highest number of USFDA-compliant companies with plants outside the US.
(The above story is verified and authored by Press Trust of India (PTI) staff. PTI, India’s premier news agency, employs more than 400 journalists and 500 stringers to cover almost every district and small town in India.. The views appearing in the above post do not reflect the opinions of LatestLY)