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Zydus, Dr Reddy's recall products in US over manufacturing issues

Written By : Ruchika Sharma |Medically Reviewed By : Dr. Kamal Kant Kohli   |  
Dr Reddys, Zydus recall products in US over manufacturing issues
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New Delhi: Pharmaceutical giants Dr Reddy's Laboratories and Zydus Lifesciences are recalling products from the U.S. market due to manufacturing-related issues, according to the U.S. Food and Drug Administration's latest Enforcement Report.

An American subsidiary of Hyderabad-based Dr Reddy's Laboratories is recalling 571 vials of Succinylcholine Chloride Injection, a medication used to relax muscles. The recall was initiated after an "Out-of-Specification result during the six-month stability testing," the USFDA stated.

Princeton-based Dr Reddy's Laboratories, Inc. initiated the nationwide (US) Class II recall on September 26 this year.

As per a PTI report, US-based arm of Zydus Lifesciences is also recalling over 1,500 boxes of an antiviral medication used primarily to treat chronic hepatitis B virus.

Pennington, New Jersey-based Zydus Pharmaceuticals (USA) Inc is recalling 912 and 600 bottles of Entecavir tablets in strengths of 0.5 mg and 1 mg respectively due to "failed impurity/degradation specifications," it added.
The drug firm initiated the Class II nationwide recall on September 24.
As per the USFDA, a Class-II recall is initiated when the use of, or exposure to, a violative product may lead to temporary or medically reversible health consequences, or when the likelihood of serious adverse health outcomes is minimal.
India has the highest number of USFDA-compliant pharmaceutical plants outside of the US.
Last month, several drugmakers including Sun Pharma, Zydus, Glenmark, Granules India, and Unichem also recalled products in the United States due to various manufacturing concerns.
In July, Dr Reddy's Laboratories, Sun Pharma, and Lupin
were among the companies that recalled products from the US market due to manufacturing issues and product mix-ups.

Established in 1984, Dr. Reddy’s Laboratories Ltd. is a global pharmaceutical company headquartered in Hyderabad, India. Zydus Lifesciences Ltd. is an innovative, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies.

dr reddys labsdr reddys labs newszydus lifesciencesrecallUSFDASuccinylcholine Chloride Injectionhepatitis BEntecavir tablets
Source : with inputs
Ruchika Sharma
Ruchika Sharma

    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

    Dr. Kamal Kant Kohli
    Dr. Kamal Kant Kohli

    Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751

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