Virazole — Class II drug recall D-0379-2015
Terminated recall by Valeant Pharmaceuticals North America LLC, reported 2015-01-28, distributed nationwide. Non-Sterility: Valeant's laboratory observed a positive microbial contamination of Virazole lot 340353F, durin
| Recall number | D-0379-2015 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Valeant Pharmaceuticals North America LLC, Bridgewater, NJ, United States |
| Recall initiated | 2014-12-31 |
| Classified | 2015-01-22 |
| Reported by FDA | 2015-01-28 |
| Terminated | 2017-10-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU |
| Quantity | 2,428 vials |
| Reason classes | microbial contamination, sterility, specification failure |
| NDC | 00187-0007-14 |
| Lot numbers | 340353F |
| Expiration dates | 2018-10 |
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 for recall
Non-Sterility: Valeant's laboratory observed a positive microbial contamination of Virazole lot 340353F, during testing at the 12 month stability pull.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0379-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.