Valeant Recalls One Lot of Virazole
Valeant Pharmaceuticals North America LLC (VPNA) is issuing a voluntarily recall of one lot of Virazole (ribavirin powder for solution), 100 mL, 6 g vial, 4-pack to the user level.
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 October 2018. Virazole was distributed in the US and Australia.
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 (because of underlying disease), and are more susceptible. 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.
Valeant 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.
Source: Valeant Pharmaceuticals and FDA