Drug product

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.

D-0031-2025

October 10, 2024

Class II

Product summary

Firm: ACCORD HEALTHCARE, INC.
Event: Event 95501
Status: Ongoing
Classification: Class II
Quantity: N/A
Official record key: drug-enforcement:D-0031-2025

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: 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 pattern: Nationwide in the USA and PR

Derived failure modes

Foreign material or chemical contamination
reason.foreign_material_chemical_contamination · v1.0.0

nitrosamine impurity
Manufacturing or process control
reason.manufacturing_process_control · v1.0.0

CGMP Deviations