Last Updated on December 31, 2023 by The Health Master
Home-grown drug makers Zydus Lifesciences and Lupin are recalling products in the US, the world’s largest market for medicines, owing to manufacturing issues.
As per the Enforcement Report by the US Food and Drug Administration (USFDA), Zydus Lifesciences (formerly known as Cadila Healthcare) is recalling 1,116 boxes of Fulvestrant Injection, a drug that 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 of 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 Lupin Ltd., is recalling the affected lot due to “Current Good Manufacturing Practice (CGMP) deviations.”
The drug initiated a Class II recall on July 28 of 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.
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