AvKARE: Drug Recall

Recall #D-0109-2025 · 11/27/2024

Class II: Risk

Recall Details

Recall Number
D-0109-2025
Classification
Class II
Product Type
Drug
Recalling Firm
AvKARE
Status
Ongoing
Date Initiated
11/27/2024
Location
Pulaski, TN, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2,396 bottles

Reason for Recall

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

Product Description

Cinacalcet Tablets, 60 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-460-30

Distribution Pattern

USA Nationwide

Other Recalls by AvKARE

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Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.