FDA Drug recall D-0379-2015
Virazole (Ribavirin for Inhalation Solution, USP), Sterile Lyophilized For Administration by Aerosol Inhalation Only, Rx only, Contents: Fo…
- FDA Drug
- Class II
- terminated
- Published 2015-01-28
On 2015-01-28 the FDA classified a Class II recall of Virazole (Ribavirin for Inhalation Solution, USP), Sterile Lyophilized For Administration by Aerosol Inhalation Only, Rx only, Contents: Fo… by Valeant Pharmaceuticals North America, citing non-Sterility: Valeant's laboratory observed a positive microbial contamination of Virazole lot 340353F, during testing at the 12 month stability pull.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0379-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-12-31 |
| Published | 2015-01-28 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Valeant Pharmaceuticals North America |
| Distribution | US |
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.
Reason
Non-Sterility: Valeant's laboratory observed a positive microbial contamination of Virazole lot 340353F, during testing at the 12 month stability pull.
Identifiers
| code_info | Lot #: 340353F, Exp 10/2018 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0379-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.