Class II
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.
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
- Recall number
- D-0031-2025
- Report date
- November 6, 2024
- Classification
- Class II
- Status in dataset
- Ongoing
- Recalling firm
- ACCORD HEALTHCARE, INC.
- Generic names
- CINACALCET
- Brand names
- CINACALCET
- Product NDCs
- 16729-440, 16729-441, 16729-442
Code and lot information
a) Lot #: Expiry Date: M2204481 02/2025 M2212389 08/2025 M2214271 09/2025 M2215970 10/2025 M2216458 10/2025 b) Lot #: Expiry Date: M2212869 08/2025 M2216362 09/2025 M2215969 10/2025
Distribution
Nationwide in the USA and PR
Source and limitations
This page reflects a public openFDA Drug Enforcement record. The dataset was last checked on September 23, 2026. openFDA states that enforcement data should not be used alone to issue public alerts or track the full lifecycle of a recall.
Review the official FDA Drug Recalls page and the underlying openFDA query.