Drug product

Cinacalcet Tablets, 30 mg, packaged in: a) 30-count HDPE bottle (NDC 65862-831-30); b) 500-count HDPE bottle (NDC 65862-831-05), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road, East Windsor, NJ 08520, Made in India.

D-0077-2025

November 07, 2024

Class II

Product summary

Firm: Aurobindo Pharma USA Inc
Event: Event 95730
Status: Ongoing
Classification: Class II
Quantity: 102576 bottles
Official record key: drug-enforcement:D-0077-2025

Official wording

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

Code information: Lot #: a) CFSA23001A, CFSA23002A, CFSA23003A, Exp 03/31/2025; CFSA23004A, Exp 07/31/2025; CFSA23005A, Exp 10/31/2025; b) P2300191, P2300192, P2300193, P2300194, Exp 12/31/2024

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