Dr Reddy's Labs recalls over 3 lakh bottles of Cinacalcet tablets in US over manufacturing issues

Written By : Ruchika Sharma |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2024-11-05T13:30:33+05:30 | Updated On 5 Nov 2024 1:30 PM IST

New Delhi: Dr Reddy's Laboratories is recalling over 3.3 lakh bottles of Cinacalcet tablets, a medication used for treatment of high calcium levels in the blood and hyperparathyroidism, in the U.S. market over manufacturing issues.

The U.S. Food and Drug Administration (FDA) Enforcement Report states that Dr. Reddy's is recalling 331,590 bottles of Cinacalcet tablets in various strengths due to deviations from current good manufacturing practices (CGMP) in the American market. The recall is due to the presence of N-nitroso Cinacalcet impurity above the FDA recommended interim limit.

As per PTI, New Jersey-based Dr Reddy's Laboratories, Inc., a unit of Hyderabad-based drug major, is recalling 2,85,126 bottles of Cinacalcet tablets in 30 mg strength.

Besides, the drug maker is recalling 35,880 and 10,584 bottles of 60 mg and 90 mg strengths, respectively, USFDA said.

The affected lot has been produced in India, it added.

US-based Dr Reddy's Laboratories, Inc. initiated the Class II nationwide (US) recall on October 9 this year.

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

The Indian pharmaceutical industry is the world's third-largest by volume and 14th-largest in value terms.

The US generic drug market was estimated to be around USD 115.2 billion in 2019. It is the largest market for pharmaceutical products.

Read also: Dr Reddy's Laboratories gets CDSCO Panel Nod To Import and Market Toripalimab 240mg solution for infusion

Established in 1984, Dr. Reddy’s Laboratories Ltd. is a global pharmaceutical company headquartered in Hyderabad, India. The Company offers a portfolio of products and services including APIs, generics, branded generics, biosimilars and OTC. Its major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Dr Reddy's Labs major markets include – USA, India, Russia & CIS countries, China, Brazil and Europe.

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Source : with inputs

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-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