Cinacalcet Hydrochloride Tablets, 60 Mg, 30 Tablets Per Bottle, Rx Only, Manufactured For: Cipla Usa, Inc., 10 Independence Boulevard, Suite 300, Warren, Nj 07059. Ndc: 69097-411-02
Cinacalcet Hydrochloride Tablets 60 mg manufactured by Cipla USA are being recalled nationwide because they contain higher-than-acceptable levels of a nitrosamine impurity called N-nitroso-cinacalcet. This is a Class I recall, the most serious type. The affected product is identified by NDC number 69097-411-02 and was distributed throughout all U.S. states and Washington, D.C.
- Recalling firm
- Cipla USA, Inc.
- Product
- Cinacalcet Hydrochloride Tablets, 60 mg, 30 Tablets per bottle, Rx Only, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC: 69097-411-02
- Reason
- CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits.
- Classification
- Class I
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2025-11-14
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Nationwide in the US
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/900a5ca2-d395-465a-9bb5-dad8715c9b39