Virazole Recall Issued Due to Microbial Contamination Risk

Federal health officials are warning that at least one lot of the lung infection drug Virazole may be contaminated with dangerous bacteria. 

A Virazole inhalation solution recall was announced by the FDA on December 31, after the manufacturer, Valeant Pharmaceuticals, discovered that a certain lot may be contaminated with bacteria. To date, no injuries or adverse health events have been recorded.

Virazole is a product that is composed of ribavirin powder, which is reconstituted with 300mL sterile water for injection of for inhalation by young children or infants who suffer from severe lower respiratory tract infections due to respiratory syncytial virus (RSV).

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Inhalation and injection methods of Virazole solutions are only used for the treatment of hospitalized infants and young children who suffer from severe symptoms of RSV, whereas most treatments are curable through non anti-viral drugs.

The potentially contaminated solutions can significantly heighten the health risk to young children already suffering from the infection. The inhalation of non-sterile products containing bacteria directly entering their airways can increase the risk of respiratory infection, especially those who suffer from underlying diseases and are more vulnerable.

The recall includes Virazole ribavirin powder for solution packaged in 100mL, 6 g Vial, 4-packs that are to be reconstituted with 300 mL Sterile Water for injection or for inhalation. The products packaging contains NDC number 00187-0007-14. The affected Virazole products contain Lot number 340353F and have the expiration date “Oct-2018.

The products were manufactured by Valeant Pharmaceuticals North America LLC (VPNA). They were sold in the United States and Australia.

VPNA has begun notifying customers and its distributors by mail and is arranging for return of all recalled products included in the affected lot. The FDA and the company recommend that customers with Virazole solutions check the products packaging to verify the recalled lot number and contact VPNA at 800-321-4576 or email them at pharmcs@valeant.com for instructions. Caregivers to patients should be cautious and contact their physician or healthcare provider for questions regarding the products.

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