Recall D-0675-2026
Recalling firm
Cipla USA, Inc., NJ
Product
Cinacalcet Hydrochloride Tablets, 60 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 69097-411-02
Reason for recall
cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI).