Class IIReported 2025-03-26

Cinacalcet Hydrochloride Tablets 60 mg, 30-count bottle, Rx only, Distr. by: Slate Run Pharma., LLC, Columbus, Ohio 43215, Mfg. by: Piramal Pharma Limited, Madhya Pradesh, India, NDC 70436-008-04

Reason for Recall

CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.

Recall Number

D-0279-2025

Classification

Class II

Status

Ongoing