Recall D-0108-2025

US Class II Ongoing · initiated 2024-11-27

Recalling firm

AvKARE, TN

Product

Cinacalcet Tablets, 30 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-459-30

Reason for recall

CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.

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