Recalls / Class II
Class IID-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.
- 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: 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
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-0030-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.