Drug product
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.
D-0032-2025
Product summary
- Event
- Event 95501
- Status
- Ongoing
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-0032-2025
Official wording
Reason: CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Code information: a) Lot #: Expiry Date: M2303264 01/2026 b) Lot #: Expiry Date: M2306979 04/2026
Distribution pattern: Nationwide in the USA and PR
Derived failure modes
-
Foreign material or chemical contamination
nitrosamine impurity
-
Manufacturing or process control
CGMP Deviations