FDAFDA · Food and drugs·Recall number D-0027-2025
Cinacalcet Tablets, 60 mg, 30-count bottles, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India, NDC 43598-368-30.
Published November 6, 2024 · Recall initiated: October 9, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- CINACALCET
- Manufacturer
- Dr. Reddy's Laboratories, Inc.
- Distributor
- USA Nationwide.
- UPC
- 0343598369303
- Lot
- Lot# T2200698, Exp 01/2025; T2201444, Exp 03/2025; T2202827, Exp 06/2025; T2300531, Exp 12/2025; T2301696, Exp 02/2026; T2304726, Exp 08/2026; T2400480, Exp 11/2026.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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