FDARecalled Dec 11, 2024 · #D-0110-2025
Cinacalcet Tablets, 90 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-461-30
Hazard
Class II — temporary health risk
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CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit. Classification: Class II Distribution: USA Nationwide
Product details
- Product
- Cinacalcet Tablets, 90 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-461-30
- Type
- Drugs
- Manufacturer
- AvKARE
- Model numbers
- 44405
- UPCs
- —