Sun Pharma, a major drug company, is recalling around 55,000 bottles of a generic medication used to treat bowel disease in the United States, according to the US Food & Drug Administration (USFDA). The latest report from the US health regulator reveals that Sun Pharmaceutical Industries Inc, based in New Jersey and a unit of the Mumbai-based drug company, is recalling 54,960 bottles of Mesalamine extended-release capsules in the American market.
These capsules are typically prescribed for the treatment of mild to moderate ulcerative colitis.
The affected batch of capsules was manufactured by Sun Pharmaceutical Industries at its plant in Mohali and distributed in the US market by Sun Pharmaceutical Industries Inc.
The USFDA states that the company has initiated a Class II recall due to “Failed Dissolution Specifications.”
The company started the Class II recall on February 5 this year.
In simple terms, a Class II recall is launched when using or being exposed to a product that violates specifications may lead to temporary or medically reversible adverse health effects, or when the likelihood of serious adverse health effects is low. The US generic drug market was valued at around USD 115.2 billion in 2019, making it the largest market for pharmaceutical products.
Sun Pharma is a leading generic pharmaceutical company in the United States.
