Class IIOngoing

Cinacalcet Tablets recall

FDA recall D-0110-2025 · initiated Nov 27, 2024

May cause temporary or medically reversible harm; low probability of serious harm.

Why it was recalled

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

Details

Product: Cinacalcet Tablets, 90 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-461-30
Recalling company: AvKARE
Classification: Class II
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: USA Nationwide
Initiated: Nov 27, 2024
FDA report date: Dec 11, 2024

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0110-2025 ↗

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