D-0031-2025 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- November 6, 2024
- Initiation Date
- October 10, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
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.
Reason for Recall
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Distribution Pattern
Nationwide in the USA and PR
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