Virazole recalled over sterility concerns
- Recall date
- December 31, 2014
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Valeant Pharmaceuticals North America LLC recalls Virazole (Ribavirin for Inhalation Solution, USP), Sterile Lyophilized For Administration by Aerosol Inhalation Only, R…
- Recall number
- D-0379-2015
- FDA classification
- Class II
- Brand / firm
- Valeant Pharmaceuticals North America LLC
- Sold / distributed
- Nationwide and Australia
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.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
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.
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