New Delhi: The US Food and Drug Administration (USFDA) has said that Sun Pharma and Dr. Reddy's Laboratories are recalling their products from the US market due to manufacturing issues.
In its latest enforcement report, the US health regulator said a US-based unit of Sun Pharma is recalling 35,069 bottles of the drug used to treat high pressure inside the eye caused by glaucoma or other eye diseases.
New Jersey-based Sun Pharmaceutical Industries Inc. is recalling affected LOs of Zelpros (latanoprost ophthalmic emulsion) due to being "out of specification for particulate matter test."
The USFDA said the company initiated a voluntary Class III recall in the US on April 22 this year.
In a separate filing, the USFDA said the US-based arm of Dr Reddy's Laboratories is recalling 1,176 bottles of an immunosuppressant drug. The USFDA said D. Reddy's Laboratories Inc. is recalling the affected sirolimus tablets due to "failed impurities/degradation specifications."
The company initiated the Class III recall on May 1, 2024.
According to the USFDA, a Class III recall is initiated in a situation where exposure to or exposure to a violative product is unlikely to result in adverse health consequences.
India is the largest supplier of generic drugs with about 20 per cent share in the global supply, manufacturing 60,000 different generic brands across 6 therapeutic categories.
Products manufactured in the country are shipped to more than 200 countries around the world, with Japan, Australia, Western Europe and the US being the main destinations.
India has the highest number of USFDA-compliant companies with plants outside the US.
In its latest enforcement report, the US health regulator said a US-based unit of Sun Pharma is recalling 35,069 bottles of the drug used to treat high pressure inside the eye caused by glaucoma or other eye diseases.
New Jersey-based Sun Pharmaceutical Industries Inc. is recalling affected LOs of Zelpros (latanoprost ophthalmic emulsion) due to being "out of specification for particulate matter test."
The USFDA said the company initiated a voluntary Class III recall in the US on April 22 this year.
In a separate filing, the USFDA said the US-based arm of Dr Reddy's Laboratories is recalling 1,176 bottles of an immunosuppressant drug. The USFDA said D. Reddy's Laboratories Inc. is recalling the affected sirolimus tablets due to "failed impurities/degradation specifications."
The company initiated the Class III recall on May 1, 2024.
According to the USFDA, a Class III recall is initiated in a situation where exposure to or exposure to a violative product is unlikely to result in adverse health consequences.
India is the largest supplier of generic drugs with about 20 per cent share in the global supply, manufacturing 60,000 different generic brands across 6 therapeutic categories.
Products manufactured in the country are shipped to more than 200 countries around the world, with Japan, Australia, Western Europe and the US being the main destinations.
India has the highest number of USFDA-compliant companies with plants outside the US.
