Dr Reddy’s recalls over 3.3 lakh bottles of generic medication in U.S.: USFDA

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Dr Reddy’s Laboratories is recalling over 3.3 lakh bottles of a medication used to treat high calcium levels in the blood and hyperparathyroidism in the U.S. market due to manufacturing issues.

According to the latest Enforcement Report by the US Food and Drug Administration, Dr Reddy’s is recalling the 3,31,590 bottles of Cinacalcet tablets in multiple strengths in the American market due to CGMP (current good manufacturing practice) deviations.

The recall is due to the “presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit”, it added.

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.

Class II nationwide recall

U.S.-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 U.S. generic drug market was estimated to be around $115.2 billion in 2019. It is the largest market for pharmaceutical products.