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Dr. Reddy’s Laboratories is recalling over 3.3 lakh bottles of the drug, used to treat high calcium levels in the blood and hyperparathyroidism, from the US market due to manufacturing issues.
According to the latest enforcement report by the US Food and Drug Administration, Dr Reddy’s is recalling 3,31,590 bottles of Cinacalcet tablets in multiple strengths in the US market due to CGMP (Current Good Manufacturing Practice) deviations.
It says the recall is due to “the presence of N-nitroso cinacalcet impurity above the interim limit recommended by the FDA.”
New Jersey-based Dr. Reddy’s Laboratories, Inc., a unit of the Hyderabad-based drug company, is recalling 2,85,126 bottles of Cinacalcet tablets of 30 mg strength.
Additionally, the drugmaker is recalling 35,880 and 10,584 bottles of 60 mg and 90 mg, respectively, the USFDA said.
It said the affected lots were produced in India.
Second class nationwide recall
US-based Dr. Reddy’s Laboratories, Inc. initiated a nationwide (US) Class II recall on October 9 this year.
According to the USFDA, a Class II recall is initiated when use of or exposure to a violative product is likely to cause temporary or medically reversible adverse health consequences or where the likelihood of serious adverse health consequences is very low. Is.
The Indian pharmaceutical industry is the world’s third largest by volume and 14th largest by value.
The US generic drug market was estimated to be worth approximately $115.2 billion in 2019. It is the largest market for pharmaceutical products.
published – November 03, 2024 04:19 PM IST