FDARecalled Dec 17, 2025 · #D-0225-2026
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
Hazard
Class II — temporary health risk
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CGMP Deviations: the presence of a nitrosamine impurity, N-nitroso-cinacalcet, above the acceptable daily intake (ADI) limits. Classification: Class II Distribution: Nationwide in the US
Product details
- 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
- Type
- Drugs
- Manufacturer
- Cipla USA, Inc.
- Model numbers
- 5PB0164
- UPCs
- —