Drug product
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.
D-0379-2015
Product summary
- Event
- Event 70123
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,428 vials
- Official record key
drug-enforcement:D-0379-2015
Official wording
Reason: Non-Sterility: Valeant's laboratory observed a positive microbial contamination of Virazole lot 340353F, during testing at the 12 month stability pull.
Code information: Lot #: 340353F, Exp 10/2018
Distribution pattern: Nationwide and Australia
Derived failure modes
-
Microbial contamination
microbial contamination