Class IIOngoing

Cinacalcet Tablets recall

FDA recall D-0031-2025 · initiated Oct 10, 2024

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

Why it was recalled

CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.

Details

Product: Cinacalcet Tablets, 60 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-441-10, b) 90 Tablets per bottle, NDC: 16729-441-15, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad - 382 210, INDIA.
Recalling company: ACCORD HEALTHCARE, INC.
Classification: Class II
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: Nationwide in the USA and PR
Initiated: Oct 10, 2024
FDA report date: Nov 6, 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-0031-2025 ↗

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