According to an FDA press release, Valeant Pharmaceuticals North America (VPNA) issued a voluntarily recall of one lot of Virazole (ribavirin powder for solution) due to microbial contamination, 100 mL, 6g Vial, 4-pack to the user level.
Virazole is indicated for the treatment of hospitalized infants and young children with severe lower respiratory tract infections due to respiratory syncytial virus (RSV). Valeant has not received reports of adverse events or injuries, related to this recall.
Virazole is packaged in 100 mL, 6 g Vial, 4-pack NDC 00187-0007-14 which is to be reconstituted with 300 mL Sterile Water for Injection or Sterile Water for Inhalation (no preservatives added) 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.
VPNA is notifying its distributors and customers by mail and is arranging for return of all recalled product of this lot. This recall only affects this lot of Virazole; all other lots are not affected and are not involved in this recall.
Customers with questions regarding this recall can contact VPNA by phone at 800-321-4576 Monday - Friday, 8am - 5pm (Eastern) or by e-mail address at firstname.lastname@example.org. Consumers should contact their physician or healthcare provider for questions regarding this product. Read the full release