Class II Recall

Cipla USA, Inc.

Product
Cinacalcet Hydrochloride Tablets, 90 mg, 30-count bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, NDC 69097-412-02
Reason
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).
Classification
Class II
Status
Ongoing
Lot
Lot #: 5PB0563, Exp 4/30/2027
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.