Sun Pharma unit recalls over 54000 bottles of Mesalamine ER capsules in US
The affected lot of capsules have been manufactured by Sun Pharmaceutical Industries at its Mohali-based manufacturing plant and distributed in the US market by Sun Pharmaceutical Industries Inc.
New Delhi: Sun Pharma is recalling about 55,000 bottles of a generic medication to treat bowel disease in the American market, according to the US Food & Drug Administration (USFDA).
As per the latest Enforcement Report by the US health regulator, New Jersey-based Sun Pharmaceutical Industries Inc, a unit of the Mumbai-headquartered drug major, is recalling 54,960 bottles of Mesalamine extended-release capsules in the American market.
Mesalamine delayed-release capsules are indicated for the treatment of mild to moderate ulcerative colitis.
The affected lot of capsules have been manufactured by Sun Pharmaceutical Industries at its Mohali-based manufacturing plant and distributed in the US market by Sun Pharmaceutical Industries Inc.
As per the USFDA, the company has initiated the Class II recall due to "Failed Dissolution Specifications".
The company initiated the Class II recall on February 5 this year.
Read also: Sun Pharma Gets CDSCO Panel Nod to Study Tildrakizumab Injection 100 mg/ ml
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.
The US generic drug market was estimated to be around USD 115.2 billion in 2019. It is the largest market for pharmaceutical products.
Sun Pharma is one of the leading generic pharmaceutical companies in the US.
Read also: Lupin, Sun Pharma recall rheumatoid arthritis, thyroid drugs in US
Sun Pharma is an Indian multinational pharmaceutical company headquartered in Mumbai, Maharashtra. The company manufactures and markets a large basket of pharmaceutical formulations covering a broad spectrum of chronic and acute therapies. It includes generics, branded generics, specialty, complex or difficult-to-make technology-intensive products, over-the-counter (OTC), antiretrovirals (ARVs), Active Pharmaceutical Ingredients (APIs), and Intermediates.
Read also: Sun Pharma to buy 16.33 percent stake in Surgimatix for over Rs 25 crore
