Class II
Terminated
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.
- Recall Initiated
- December 31, 2014
- Posted
- January 28, 2015
- Recall Number
- D-0379-2015
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 2,428 vials
- Firm Location
- Bridgewater, NJ, United States
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.
Distribution
Nationwide and Australia
Lot / Code Info
Lot #: 340353F, Exp 10/2018
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