Drug recall D-0027-2025
Product
Cinacalcet Tablets, 60 mg, 30-count bottles, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India, NDC 43598-368-30.
Reason for recall
CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Lots and codes
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.
Recall details
- Recalling firm
- Dr. Reddy's Laboratories, Inc., Princeton, NJ
- Quantity
- 35880 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