ACCORD HEALTHCARE, INC. — Cinacalcet Tablets 30 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-440-10, b) 90 Tablets per bottle, NDC: 16729-440-15, Manufactured for: Accord Healthcare, Inc., Durham
⚠️ CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- October 10, 2024
Nationwide in the USA and PR
What's affected?
- Product
- Cinacalcet Tablets 30 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-440-10, b) 90 Tablets per bottle, NDC: 16729-440-15, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured by: Intas Pharmaceuticals Limited, Ahmedabad - 382 210, INDIA.
- Brand
- CINACALCET
- Lot code
- Expiry
Additional details
a) Lot #: Expiry Date: M2118190 11/2024 M2201091 11/2024 M2206241 11/2024 M2206451 04/2025 M2208674 06/2025 M2213850 08/2025 M2215221 09/2025 M2216236 11/2025 M2217098 11/2025 M2300664 11/2025 b) Lot #: Expiry Date: M2210808 06/2025 M2212212 08/2025 M2214435 09/2025 M2217097 11/2025 M2301921 01/2026
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: N/A.
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