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 US market due to manufacturing issues.
The latest Enforcement Report by the US Food and Drug Administration said that 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.
It mentioned that the recall is due to the presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit.
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.
USFDA said that the drug maker is recalling 35,880 and 10,584 bottles of 60 mg and 90 mg strengths, respectively. The affected lot has been produced in India, it added.
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.