Drug recall D-0030-2025
Product
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.
Lots and codes
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
Recall details
- Recalling firm
- ACCORD HEALTHCARE, INC., Raleigh, NC
- Quantity
- N/A
- Distribution
- Nationwide in the USA and PR
- Type
- Voluntary: Firm initiated
- Recall initiated
- October 10, 2024
Related products
- Cinacalcet – drug information
- NDC 16729-440 Cinacalcet · Cinacalcet Hydrochloride 30 mg/1 · Accord Healthcare, Inc.
- NDC 16729-441 Cinacalcet · Cinacalcet Hydrochloride 60 mg/1 · Accord Healthcare, Inc.
- NDC 16729-442 Cinacalcet · Cinacalcet Hydrochloride 90 mg/1 · Accord Healthcare, Inc.