Recall D-0278-2025

US Class II Completed · initiated 2025-03-07

Recalling firm

Slate Run Pharmaceuticals, OH

Product

Cinacalcet Hydrochloride Tablets 30 mg, 30-count bottle, Rx only, Distr. by: Slate Run Pharma., LLC, Columbus, Ohio 43215, Mfg. by: Piramal Pharma Limited, Madhya Pradesh, India, NDC 70436-007-04

Reason for recall

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

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