Drug recall D-0028-2025
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.
Reason for recall
CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Lots and codes
Lot# T2201443, Exp 03/2025; T2300664, Exp 12/2025.
Recall details
- Recalling firm
- Dr. Reddy's Laboratories, Inc., Princeton, NJ
- Quantity
- 10584 bottles
- Distribution
- USA Nationwide.
- Type
- Voluntary: Firm initiated
- Recall initiated
- October 9, 2024
Related products
- Cinacalcet – drug information
- NDC 43598-367 Cinacalcet · Cinacalcet Hydrochloride 30 mg/1 · Dr. Reddys Laboratories Inc
- NDC 43598-368 Cinacalcet · Cinacalcet Hydrochloride 60 mg/1 · Dr. Reddys Laboratories Inc