Drug recall D-0031-2025
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.
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: 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
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.