Valeant Pharmaceuticals North America LLC Issues Voluntary Recall Of Virazole® (Ribavirin Powder For Solution) In The United States
Dec. 30, 2014 /PRNewswire/ -- Valeant Pharmaceuticals North America LLC (VPNA) is issuing a Class 2 voluntarily recall of one (1) lot of Virazole® (ribavirin powder for solution), 100mL, 6g Vial, 4-pack to the Hospital level. The product has been found to have an observed sterility positive during testing at 12 months.
Virazole is indicated for the treatment of hospitalized infants and young children with severe lower respiratory tract infections due to respiratory syncytial virus (RSV). Valeant has not received reports of adverse events or injuries, related to this recall.
Virazole is packaged in 100mL, 6g Vial, 4-pack NDC 00187-0007-14. The affected Virazole lot is Lot No. 340353F with an expiration date of Oct-2018. Virazole was distributed in the U.S. and Australia.
VPNA is notifying its distributors and customers by mail and is arranging for return of all recalled product of this lot. This recall only affects this lot of Virazole; all other lots are not affected and are not involved in this recall.
Customers with questions regarding this recall can contact VPNA by phone at 800-321-4576 or by e-mail address at pharmcs@valeant.com. Consumers should contact their physician or healthcare provider for questions regarding this product.
Adverse reactions or quality problems experienced with the use of this product may be reported to VPNA at 877-361-2719 or to the FDA's MedWatch Adverse Event Reporting program as follows:
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted in conjunction with the U.S. Food and Drug Administration.
About Valeant Pharmaceuticals North America LLC:
Valeant Pharmaceuticals North America LLC, is a specialty pharmaceutical company that develops, manufactures and markets a broad range of pharmaceutical products primarily in the areas of dermatology, eye health, consumer healthcare and other pharmaceutical products. More information about Valeant can be found at www.valeant.com.
Contact Information:
Laurie W. Little
949-461-6002
laurie.little@valeant.com
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SOURCE Valeant Pharmaceuticals North America LLC