Class II
Ongoing
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.
This recall is currently active, issued November 6, 2024. It was issued by Accord Healthcare, Inc..
- Company
- Accord Healthcare, Inc.
- Recall Initiated
- October 10, 2024
- Posted
- November 6, 2024
- Recall Number
- D-0032-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Firm Location
- Raleigh, NC, United States
- Official Source
- View on FDA website ↗
Reason for Recall
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Distribution
Nationwide in the USA and PR
Lot / Code Info
a) Lot #: Expiry Date: M2303264 01/2026 b) Lot #: Expiry Date: M2306979 04/2026
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