Class II
Ongoing
Cinacalcet Tablets, 90 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India., NDC 43598-369-30.
This recall is currently active, issued November 6, 2024. It was issued by Dr. Reddy'S Laboratories, Inc..
- Company
- Dr. Reddy'S Laboratories, Inc.
- Recall Initiated
- October 9, 2024
- Posted
- November 6, 2024
- Recall Number
- D-0028-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 10584 bottles
- Firm Location
- Princeton, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Distribution
USA Nationwide.
Lot / Code Info
Lot# T2201443, Exp 03/2025; T2300664, Exp 12/2025.
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