FDA-Drug2015-01-28Class II
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.
Valeant Pharmaceuticals North America LLC
Hazard
Non-Sterility: Valeant's laboratory observed a positive microbial contamination of Virazole lot 340353F, during testing at the 12 month stability pull.
Sold states
Nationwide and Australia
Affected count
2,428 vials
Manufactured in
400 Somerset Corporate Blvd, N/A, Bridgewater, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0379-2015Don't want to check this manually?
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