Product: Cinacalcet Tablets, 60 mg, 30-count bottles, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India, NDC 43598-368-30.
Reason for recall: CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Recall initiated: 20241009
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated