Class IIReported 2024-12-11

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.

Reason for Recall

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

Recall Number

D-0077-2025

Classification

Class II

Status

Ongoing