Zydus Lifesciences and Lupin recall products in US
While Zydus Lifesciences is recalling products due to failed impurities/degradation specifications, Lupin is doing it due to CGMP deviations
Zydus Lifesciences and Lupin are recalling products in the US due to manufacturing issues.
As per the Enforcement Report by the US Food and Drug Administration (USFDA), Zydus Lifesciences is recalling 1,116 boxes of Fulvestrant injection, a drug used to treat breast cancer.
According to the FDA, the company’s US-based unit is recalling the affected lot due to “Failed Impurities/Degradation Specifications.”
The affected lot has been manufactured in India and has been distributed in the US by New Jersey-based Zydus Pharma (USA), the report stated.
Zydus initiated the class-II voluntary recall on 15th July this year.
Similarly, Baltimore-based Lupin Pharmaceuticals is recalling 7,872 bottles of Rifampin Capsules, a medication used to treat infections caused by bacteria.
The company is recalling the affected lot due to “Current Good Manufacturing Practice (CGMP) deviations.”
The drug initiated the class-II recall on 28th July this year.
Edits by EP News Bureau
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