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

Recall Number: D-0279-2025

Firm: Slate Run Pharmaceuticals

Classification: Class II

Status: Completed

Report Date: 20250326

Initiation Date: 20250307

Termination Date:

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

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