Drug product

Cinacalcet Tablets, 30 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India, NDC 43598-367-30.

D-0026-2025

October 09, 2024

Class II

Product summary

Firm: Dr. Reddy's Laboratories, Inc.
Event: Event 95500
Status: Ongoing
Classification: Class II
Quantity: 285126 bottles
Official record key: drug-enforcement:D-0026-2025

Official wording

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

Code information: Lot# T2200120, T2200121, T2200119, T2200116, T2200118, T2200117, Exp 11/2024; T2200695, T2200694, T2200696, T2200697, Exp 01/2025; T2201426, T2201428, T2201432, T2201427, T2201430, T2201429, T2201431, Exp 03/2025; T2202743, T2202742, T2202741, & T2202740, Exp 06/2025; T2203081, T2203079, T2203080, T2203082, T2203083 & T2203084, Exp 07/2025; T2300770, T2300771, T2300769, T2300766, T2300767 & T2300768, Exp 12/2025 Lots T2301663, T2301665, T2301662, T2301664, T2301667, T2301661, T2301666, T2301660, T2301658 & T2301659, Exp Date 02/2026 Lots T2304704, T2304703, T2304705, T2304706, Exp Date 08/2026 Lots T2400468, T2400469, T2400473 & T2400474 Exp Date 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