Cinacalcet Tablets recalled over manufacturing violations

Recall date

November 27, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

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

Recall number

D-0109-2025

FDA classification

Class II

Brand / firm

AvKARE

Sold / distributed

USA Nationwide

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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