Virazole (Ribavirin for Inhalation Solution, USP), Sterile Lyophilized For Administration by Aero...
FDA Recall #D-0379-2015 — Class II — December 31, 2014
Product Description
Virazole (Ribavirin for Inhalation Solution, USP), Sterile Lyophilized For Administration by Aerosol Inhalation Only, Rx only, Contents: Four 6 g vials, 100 mL, Distributed by: Valeant Pharmaceuticals North America, Bridgewater, NJ 08807 USA, NDC 0187-0007-14.
Reason for Recall
Non-Sterility: Valeant's laboratory observed a positive microbial contamination of Virazole lot 340353F, during testing at the 12 month stability pull.
Recalling Firm
Valeant Pharmaceuticals North America LLC — Bridgewater, NJ
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
2,428 vials
Distribution
Nationwide and Australia
Code Information
Lot #: 340353F, Exp 10/2018
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated