Recalls / Class II
Class IID-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.
- 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# T2201443, Exp 03/2025; T2300664, Exp 12/2025.
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
- 10584 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-0028-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.