CLASS II Drug recall · Reported 28 Jan 2015 · FDA Enforcement Report
Virazole (Ribavirin for Inhalation Solution, USP) recalled
Valeant Pharmaceuticals North America is recalling Virazole (Ribavirin for Inhalation Solution, USP), Sterile Lyophilized For Administration, distributed nationwide in the US. The recall was initiated on 31 Dec 2014 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0379-2015
- FDA event ID
- 70123
- Recalling firm
- Valeant Pharmaceuticals North America, Bridgewater, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 31 Dec 2014
- FDA classified
- 22 Jan 2015
- Reported
- 28 Jan 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 31 Dec 2014 | Recall initiated by company | |
| 22 Jan 2015 | Classified by FDA | +22 days |
| 28 Jan 2015 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
Nationwide and Australia
Questions about this recall
Why was it recalled?
Non-Sterility: Valeant's laboratory observed a positive microbial contamination of Virazole lot 340353F, during testing at the 12 month stability pull.
Which lots are affected?
Lot #: 340353F, Exp 10/2018
Where was it sold?
Nationwide and Australia
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Valeant Pharmaceuticals North America
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|---|---|---|---|---|---|
| Drug | CLASS III | Cardizem CD (diltiazem HCl) capsules, 240 mg recalledCardizem Cd | Valeant Pharmaceuticals North America | Potency & Assay | Nationwide |
| Drug | CLASS III | Cardizem CD (diltiazem HCl) capsules, 180 mg recalledCardizem Cd | Valeant Pharmaceuticals North America | Potency & Assay | Nationwide |
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