Recall D-0450-2026

US Class II Ongoing · initiated 2026-03-16

Recalling firm

Cipla USA, Inc., NJ

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 for recall

CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit

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