Drug 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.

D-0027-2025

October 09, 2024

Class II

Product summary

Firm: Dr. Reddy's Laboratories, Inc.
Event: Event 95500
Status: Ongoing
Classification: Class II
Quantity: 35880 bottles
Official record key: drug-enforcement:D-0027-2025

Official wording

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

Code information: Lot# T2200698, Exp 01/2025; T2201444, Exp 03/2025; T2202827, Exp 06/2025; T2300531, Exp 12/2025; T2301696, Exp 02/2026; T2304726, Exp 08/2026; T2400480, Exp 11/2026.

Distribution pattern: USA Nationwide.

Derived failure modes

Foreign material or chemical contamination
reason.foreign_material_chemical_contamination · v1.0.0

N-nitroso Cinacalcet impurity
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0

CGMP Deviations