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FDADecember 31, 2014drug

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 recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

valeant pharmaceuticals north americavaleantvaleant pharmaceuticals

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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