Cinacalcet Tablets recalled over manufacturing violations
- Recall date
- October 10, 2024
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- ACCORD HEALTHCARE, INC. recalls Cinacalcet Tablets, 90 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-442-10, b) 90 Tablets per bottle, NDC: 16729-4…
- Recall number
- D-0032-2025
- FDA classification
- Class II
- Brand / firm
- ACCORD HEALTHCARE, INC.
- Sold / distributed
- Nationwide in the USA and PR
Why it was recalled
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
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, 90 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-442-10, b) 90 Tablets per bottle, NDC: 16729-442-15, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad - 382 210, INDIA.
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