Ribavirin Recall: Single Lot Affected
In late December 2014, Valeant Pharmaceuticals voluntarily recalled a single lot of ribavirin powder, sold under the brand name Virazole, because there were concerns with the stability of the product. The FDA is aware of the recall and is working with the company to facilitate it.
The company says that 12-month testing of Lot 340353F showed a positive sterility test result, but the company did not identify what contaminated the powder. The medication was distributed throughout the United States and Australia. All other lots are unaffected and thus not involved in the recall.
Virazole is used to treat hospitalized infants and small children who have severe lower respiratory infections as a result of respiratory syncytial virus, more commonly known as RSV. As of yet, the company has not received any reports of injuries or adverse events as a result of the recall.
The powder is intended to be reconstituted with 300 mL of sterile water for injection or sterile water for inhalation. It is administered using a small particle aerosol generator.
Under this recall, the 100 mL six gram vials in the lot were supplied in packs of four and labeled with an October 2018 expiration date. Valeant says they have notified customers by mail and are in the process of arranging the return of the recalled product.
All pharmacies with this medication in stock should check their supply to ensure they do not have any of the recalled medication. If the recalled medication is in stock, stop using it with patients and await further instruction directly from the company to facilitate the return and replacement of the product.
Pharmacists and hospitals with questions about the recall can contact the company by phone at 1-800-321-4576, from 8:00 am to 5:00 pm Eastern Time, Monday through Friday, or by email at firstname.lastname@example.org. If patients are other consumers present with questions about the recall, they should be advised to speak to their physician or other health-care provider.
Patients who have experienced any quality issues are adverse reactions associated with the use of this product can be reported to the manufacturer at 877-361-2719 or directly to the FDA via the MedWatch Adverse Event Reporting program. Patients should be directed to complete and submit the form online, or alternatively, can submit the form via regular mail or fax.