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FDARecalled Apr 22, 2026 · #D-0449-2026

Cinacalcet Hydrochloride Tablets, 30 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Cipla Ltd., MIDC, Patalganga, India; Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 30...

Hazard

Class II — temporary health risk

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Description

CGMP Deviations; presence N-Nitroso Cinacalcet above the acceptable daily intake limit Classification: Class II Distribution: Nationwide in the USA

Product details

Product
Cinacalcet Hydrochloride Tablets, 30 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: 69097-410-02
Type
Drugs
Manufacturer
Cipla USA, Inc.
Model numbers
4PB0526, 5PB0173
UPCs