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FDARecalled Dec 11, 2024 · #D-0108-2025

Cinacalcet Tablets, 30 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-459-30

Hazard

Class II — temporary health risk

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Description

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, 30 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-459-30
Type
Drugs
Manufacturer
AvKARE
Model numbers
44378
UPCs