January 6, 2015 — Valeant Pharmaceuticals, LLC is voluntarily recalling one lot of Virazole, a powdered nasal solution, due to possible microbial contamination.
There are no illnesses or injuries linked to the recalled medication. Only one lot is being recalled: Lot No. 340353F, expiration date October 2018. It was distributed in the United States and Australia.
The product is packaged in 100 mL, 6 g vials in a 4-pack. It is intended to be reconstituted using 300 mL of sterile water into a solution.
Virazole (ribavirin) is a powdered medication that is made into a solution before it is injected or inhaled by a patient. It is approved by the FDA for the treatment of infants or young children who are infected with respiratory syncytial virus (RSV).
Many patients who need Virazole already have a severe lower respiratory tract infection. Inhalation of additional bacteria could significantly worsen their condition.
The FDA warns:
“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.”
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