FDAHealthOctober 9, 2024
Dr. Reddy's Laboratories, Inc. — Cinacalcet Tablets, 60 mg, 30-count bottles, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India, NDC 43598-368-30.
⚠️ CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- October 9, 2024
USA Nationwide.
What's affected?
- 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.
- Brand
- CINACALCET
- UPC
- 0343598369303
- Lot code
- T2200698
Additional details
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.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 35880 bottles.
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