Recall D-0027-2025

US Class II Ongoing · initiated 2024-10-09

Recalling firm

Dr. Reddy's Laboratories, Inc., NJ

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

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