Class II

Drug Recall: Cinacalcet Tablets, 60 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-460-30

AvKARE · November 27, 2024

Reason for Recall

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

Distribution

USA Nationwide

States Affected

NATIONWIDE

Quantity Affected

2,396 bottles

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0109-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.