zydus: Zydus Lifesciences, Lupin recall products in US market owing to manufacturing issues

Home-grown drug makers and are recalling products in the US, the world’s largest market for medicines, owing to manufacturing issues.

As per the Enforcement Report by US Food and Drug Administration (USFDA),

Lifesciences (formerly known as ) is recalling 1,116 boxes of Fulvestrant Injection, a drug which is used to treat breast cancer.

According to the USFDA, the company’s US-based unit is recalling the affected lot due to “Failed Impurities/Degradation Specifications,” reported PTI.

The affected lot has been manufactured in India and has been distributed in the US by New Jersey-based Zydus Pharmaceuticals (USA), the report stated.

Zydus initiated the Class II voluntary recall on July 15 this year.

Similarly, Baltimore-based Lupin Pharmaceuticals, Inc, is recalling 7,872 bottles of Rifampin Capsules, a medication used to treat infections caused by bacteria.

The company, a unit of Mumbai-based

, is recalling the affected lot due to “Current Good Manufacturing Practice (CGMP) deviations.”

The drug initiated the Class II recall on July 28 this year.

As per USFDA, a Class II recall is initiated in a situation in which 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.

(With inputs from agencies)