Microbial contamination causes Valeant Pharmaceutical North America to recall Virazole
Voluntary recall is of one lot of ribavarin powder for solution
Valeant Pharmaceuticals North America, a manufacturer of pharmaceutical products to treat dermatology and eye health problems, has voluntarily recalled one lot of Virazole (ribavirin powder for solution), 100 mL, 6g vial, four-pack to the user level.
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 to infection, the company says.
Virazole is indicated for the treatment of hospitalised infants and young children with severe lower respiratory tract infections due to respiratory syncytial virus (RSV). Valeant says it has not received reports of adverse events or injuries related to this recall.
Virazole is packaged in 100mL, 6g vial, four-pack NDC 00187-0007-14 which is to be reconstituted with 300mL 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 batch is Lot No. 340353F with an expiry date of October 2018. Virazole is distributed in the US and Australia.
Valeant has notified its distributors and customers by post and is arranging for return of all recalled product of this lot. The company says no other lots are affected or involved in this recall.