Drug product
Cinacalcet Tablets, 90 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India., NDC 43598-369-30.
D-0028-2025
Product summary
- Event
- Event 95500
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 10584 bottles
- Official record key
drug-enforcement:D-0028-2025
Official wording
Reason: CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Code information: Lot# T2201443, Exp 03/2025; T2300664, Exp 12/2025.
Distribution pattern: USA Nationwide.
Derived failure modes
-
Foreign material or chemical contamination
N-nitroso Cinacalcet impurity
-
Manufacturing or process control
CGMP Deviations