FDA-Drug2024-11-06Class II

Cinacalcet Tablets, 60 mg, 30-count bottles, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India, NDC 43598-368-30.

Dr. Reddy's Laboratories, Inc.
Hazard

CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit

Sold states
USA Nationwide.
Affected count
35880 bottles
Manufactured in
107 College Rd E, N/A, Princeton, NJ, United States
Products
Cinacalcet Tablets, 60 mg, 30-count bottles, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India, NDC 43598-368-30.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0027-2025

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