Recalls / Class II
Class IID-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.
- Brand name
- Cinacalcet
- Generic name
- Cinacalcet
- Active ingredient
- Cinacalcet Hydrochloride
- Route
- Oral
- NDCs
- 43598-367, 43598-368, 43598-369
- FDA application
- ANDA208368
- Affected lot / code info
- 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.
Why it was recalled
CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Recalling firm
- Firm
- Dr. Reddy's Laboratories, Inc.
- Manufacturer
- Dr. Reddys Laboratories Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 107 College Rd E, N/A, Princeton, New Jersey 08540-6623
Distribution
- Quantity
- 35880 bottles
- Distribution pattern
- USA Nationwide.
Timeline
- Recall initiated
- 2024-10-09
- FDA classified
- 2024-10-28
- Posted by FDA
- 2024-11-06
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0027-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.