Sun Pharma recalls 55K bottles of generic medication in US

New Delhi, March 8

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.

Affected lot made in Mohali-based unit

• The drug in question is Mesalamine delayed-release capsule, indicated for the treatment of mild to moderate ulcerative colitis.
• The affected lot has been manufactured in a Mohali-based unit. The problem mentioned is “Failed Dissolution Specifications”.

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”.

As per the USFDA, a Class II recall is 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 consequences is remote.