Recalls / Class II
Class IID-0379-2015
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.
- Brand name
- Virazole
- Generic name
- Ribavirin
- Active ingredient
- Ribavirin
- Route
- Respiratory (inhalation)
- NDC
- 0187-0007
- FDA application
- NDA018859
- Affected lot / code info
- Lot #: 340353F, Exp 10/2018
Why it was recalled
Non-Sterility: Valeant's laboratory observed a positive microbial contamination of Virazole lot 340353F, during testing at the 12 month stability pull.
Recalling firm
- Firm
- Valeant Pharmaceuticals North America LLC
- Manufacturer
- Bausch Health US, LLC
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 400 Somerset Corporate Blvd, N/A, Bridgewater, New Jersey 08807
Distribution
- Quantity
- 2,428 vials
- Distribution pattern
- Nationwide and Australia
Timeline
- Recall initiated
- 2014-12-31
- FDA classified
- 2015-01-22
- Posted by FDA
- 2015-01-28
- Terminated
- 2017-10-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0379-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.