Why it was recalled
CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Product description
Cinacalcet Tablets, 90 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India., NDC 43598-369-30.
Lot numbers, UPCs & expiration codes
Lot# T2201443, Exp 03/2025; T2300664, Exp 12/2025.
Where it was sold
USA Nationwide.
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-0028-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Oct 9, 2024
- FDA report date
- Nov 6, 2024
- Quantity
- 10584 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-0028-2025, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 95500
- Address
- 107 College Rd E
- Code information
- Lot# T2201443, Exp 03/2025; T2300664, Exp 12/2025.
- Postal code
- 08540-6623
- Report date
- Nov 6, 2024
- Product type
- Drugs
- Recall number
- D-0028-2025
- Classification
- Class II
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
- Product quantity
- 10584 bottles
- Reason for recall
- CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Cinacalcet Tablets, 90 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India., NDC 43598-369-30.
- Distribution pattern
- USA Nationwide.
- Recall initiation date
- Oct 9, 2024
- Initial firm notification
- Letter
- Center classification date
- Oct 28, 2024