Recalls / Class II
Class IID-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.
- Brand name
- Cinacalcet
- Generic name
- Cinacalcet
- Active ingredient
- Cinacalcet Hydrochloride
- Route
- Oral
- NDCs
- 16729-440, 16729-441, 16729-442
- FDA application
- ANDA211892
- Affected lot / code info
- 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
Why it was recalled
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Recalling firm
- Firm
- ACCORD HEALTHCARE, INC.
- Manufacturer
- Accord Healthcare, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 8041 Arco Corporate Dr Ste 200, N/A, Raleigh, North Carolina 27617-2010
Distribution
- Quantity
- N/A
- Distribution pattern
- Nationwide in the USA and PR
Timeline
- Recall initiated
- 2024-10-10
- FDA classified
- 2024-10-31
- Posted by FDA
- 2024-11-06
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0031-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.