FDARecalled Jul 8, 2026 · #D-0676-2026
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, War...
Hazard
Class II — temporary health risk
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cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI). Classification: Class II Distribution: USA Nationwide
Product details
- 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
- Type
- Drugs
- Manufacturer
- Cipla USA, Inc.
- Model numbers
- 5PB0563
- UPCs
- —