Home / Recalls / AvKARE / D-0108-2025

D-0108-2025 Class II Ongoing

Recalled by AvKARE — Pulaski, TN

Recall Details

Product Type
Drugs
Report Date
December 11, 2024
Initiation Date
November 27, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
50,304 bottles

Product Description

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

Reason for Recall

CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.

Distribution Pattern

USA Nationwide

Code Information

Lot#: 44378, 44597, 45804, Exp 12/31/2024

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