Virazole Recalled Due to Microbial Contamination

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Valeant Pharmaceuticals is voluntarily recalling a lot of its ribavirin powder for solution (Virazole) to the user level due to microbial contamination.

Valeant Pharmaceuticals is voluntarily recalling a lot of its ribavirin powder for solution (Virazole) to the user level due to microbial contamination.

Virazole is indicated for the treatment of hospitalized infants and young children with severe lower respiratory tract infections due to respiratory syncytial virus. It 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 inhalation and administered only by a small particle aerosol generator, according to Valeant.

The lot number of the affected product is 340353F, which has an expiration date of October 2018.

Inhalation of a non-sterile product with microbial contamination into the airways could increase the risk of respiratory infection, which increases in immunocompromised patients. 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. Customers with questions regarding this recall can contact Valeant by phone at 800-321-4576 between 8 a.m. and 5 p.m. Eastern Standard Time, Monday through Friday, or by e-mail at pharmcs@valeant.com.

In addition to contacting their health care provider, patients who have experienced adverse reactions to this product should report them to the FDA's MedWatch Adverse Event Reporting program. Patients can submit the form online at www.fda.gov/medwatch/report.htm, download it at www.fda.gov/MedWatch/getforms.htm, or call 1-800-332-1088 to request it. Completed paper forms can be returned to the address on the pre-addressed form or faxed to 1-800-FDA-0178.

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