Why it was recalled
CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
Product description
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.
Lot numbers, UPCs & expiration 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
Where it was sold
Nationwide in the USA and PR
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0031-2025
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 10, 2024
- FDA report date
- Nov 6, 2024
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- ACCORD HEALTHCARE, INC.
Original FDA data
Every field from FDA enforcement report D-0031-2025, exactly as published.
Show all FDA fields
- City
- Raleigh
- State
- NC
- Status
- Terminated
- Country
- United States
- Event ID
- 95501
- Address
- 8041 Arco Corporate Dr Ste 200
- Code information
- 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
- Postal code
- 27617-2010
- Report date
- Nov 6, 2024
- Product type
- Drugs
- Recall number
- D-0031-2025
- Classification
- Class II
- Recalling firm
- ACCORD HEALTHCARE, INC.
- Termination date
- Sep 23, 2026
- Reason for recall
- CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide in the USA and PR
- Recall initiation date
- Oct 10, 2024
- Initial firm notification
- Letter
- Center classification date
- Oct 31, 2024