Nationwide Recall of Virazole for Respiratory Virus; Microbial Contamination

Valeant Pharmaceuticals North America LLC, of Bridgewater, NJ, recalled one lot of Virazole (ribavirin powder for solution), 100 mL, 6g Vial, 4-pack to the user level because it may be contaminated with microbes. Inhalation of a non-sterile product with microbial contamination into the airways could increase the risk of respiratory infection. The risk is higher in patients who are immunocompromised. Virazole is indicated for the treatment of hospitalized infants and young children with severe lower respiratory tract infections due to respiratory syncytial virus (RSV).


Virazole is packaged in 100 mL, 6 g Vial, 4-pack, with an NDC code 00187-0007-14, which is to be reconstituted with 300 mL sterile water for injection or sterile water for inhalation and administered only by a small particle aerosol generator (SPAG-2). The affected Virazole lot is Lot No. 340353F with an expiration date of Oct-2018. Virazole was distributed in the U.S. and Australia.


See the Recall


See also Medical Law Perspectives, January 2012 Report: Hospital-Acquired Infections: Who Is Liable and Why?