Cinacalcet Tablets, 60 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478,...
FDA Recall #D-0109-2025 — Class II — November 27, 2024
Product Description
Cinacalcet Tablets, 60 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-460-30
Reason for Recall
CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.
Recalling Firm
AvKARE — Pulaski, TN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
2,396 bottles
Distribution
USA Nationwide
Code Information
Lot # 44550, Exp 12/31/2024
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated