D-0030-2025 Class II Terminated
FDA drug recall D-0030-2025 was initiated by ACCORD HEALTHCARE, INC. on Oct 10, 2024 and is designated Class II. Reason for recall: CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits. The recall status is terminated (terminated Sep 23, 2026). Affected quantity: N/A.
Recall Details
- Product Type
- Drugs
- Report Date
- Nov 6, 2024
- Initiation Date
- Oct 10, 2024
- Termination Date
- Sep 23, 2026
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
Cinacalcet Tablets 30 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-440-10, b) 90 Tablets per bottle, NDC: 16729-440-15, 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: M2118190 11/2024 M2201091 11/2024 M2206241 11/2024 M2206451 04/2025 M2208674 06/2025 M2213850 08/2025 M2215221 09/2025 M2216236 11/2025 M2217098 11/2025 M2300664 11/2025 b) Lot #: Expiry Date: M2210808 06/2025 M2212212 08/2025 M2214435 09/2025 M2217097 11/2025 M2301921 01/2026