US Drug Recall Register
Class II · Moderate risk Terminated Initiated Dec 31, 2014 (12 years ago)

Virazole (Ribavirin for Inhalation Solution, USP), Sterile Lyophilized For Administration…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Non-Sterility: Valeant's laboratory observed a positive microbial contamination of Virazole lot 340353F, during testing at the 12 month stability pull.

What was recalled

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.

Recalling firm
Valeant Pharmaceuticals North America LLC
NDC code
0187-0007-14
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0379-2015

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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