Dr Reddy’s recalls over 3.3 lakh bottles of generic medicines in US: USFDA
Dr Reddy’s Laboratories is recalling over 3.3 lakh bottles of the drug used to treat high blood calcium levels and hyperparathyroidism in the US market due to manufacturing issues.
According to the latest Enforcement Report by the US Food and Drug Administration, Dr. Reddy is recalling 3,31,590 bottles of Cinacalcet multi-strength tablets from the US market due to CGMP (current good manufacturing practice) deviations.
The recall is due to “the presence of N-nitroso Cinacalcet impurities above the temporary limit recommended by the FDA”, it added. New Jersey-based Dr Reddy’s Laboratories, Inc., a Hyderabad-based drug unit, is recalling 2,85,126 bottles of Cinacalcet 30 mg tablets.
Besides, the drug maker is recalling 35,880 and 10,584 bottles of 60 mg and 90 mg strengths, respectively, the USFDA said. The affected product was manufactured in India, it added.
Dr. Reddy’s Laboratories, Inc. based in the US It started a Class II recall across the country (US) on October 9 this year. According to the USFDA, a Phase II recall is initiated in a situation where the use of, or exposure to, the offending product may cause temporary or reversible health effects or where the likelihood of adverse health effects is remote.
India’s pharmaceutical industry is the third largest in the world by volume and the 14th largest in terms of value. The US generic drug market was estimated at USD 115.2 billion in 2019. It is the largest market for pharmaceutical products.
