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Lupin, Zydus Lifesciences recall products in US over manufacturing issues
![Lupin, Zydus Lifesciences recall products in US over manufacturing issues Lupin, Zydus Lifesciences recall products in US over manufacturing issues](https://medicaldialogues.in/h-upload/2021/02/15/750x450_147848-recall.webp)
New Delhi: Home-grown drug makers Zydus Lifesciences and Lupin are recalling products in the US, the world's largest market for medicines, due to manufacturing issues.
As per the Enforcement Report by US Food and Drug Administration (USFDA), Zydus Lifesciences (formerly known as Cadila Healthcare) is recalling 1,116 boxes of Fulvestrant Injection, a drug 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".
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.
Read also: Cipla, Glenmark and 1 other recall products in US over manufacturing issues
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".
Read also: Sun Pharma, Dr Reddy's Labs and 2 others recall products in US
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.
Read also: Glenmark, Dr Reddys and 2 others recall products in US
Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751