Valeant Voluntarily Recalls One Lot of Virazole Due to Sterility Problems

December 31, 2014
Pharmaceutical Technology Editors

Valeant voluntarily recalled one lot of Virazole due to sterility problems; no adverse events have been reported to date.

 

Valeant Pharmaceuticals issued a voluntary recall on Dec. 30, 2014 for one lot of Virazole (ribavirin powder for solution), 100 mL, 6g vial, 4-pack, lot number 340353F (exp. 10/18), which was distributed to hospitals in the US and Australia. This lot of Virazole, which is used for the treatment of hospitalized infants and young children with severe lower respiratory tract infections due to respiratory syncytial virus, was determined to be non-sterile due to microbial contamination. There have not been any adverse events reported to date.

Any customers with questions regarding the recalled product may contact VPNA at 1.800.321.4576 or by email at pharmcs@valeant.com. Adverse reactions may be reported to VPNA at 877.361.2719 or to FDA’s MedWatch Adverse Event Reporting program online at www.fda.gov/medwatch/report.htm. They may also be reported through a form can be downloaded and filled out at www.fda.gov/MedWatch/getforms.htm or by calling 1.800.332.1088.

Source: FDA