Cipla Usa, Inc.: Cinacalcet Hydrochloride Tablets, 60 Mg, 30 Tablets Per Bottle
- Recalling firm
- Cipla USA, Inc.
- Product
- Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-411-02
- Reason
- CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit
- Classification
- Class II
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-03-16
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Nationwide in the USA
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/c1753404-4aa7-4950-917a-88481b0fbef2