Gilead Vistide Recall Issued Due to Particulate Matter

A recall has been issued for a specific lot of Vistide injection fluid after the manufacturer identified particulate matter found in vials, which may pose an infection hazard to consumers. 

A Gilead Sciences Vistide recall was announced by the FDA on February 15, after particulate matter was found within the cidofivor injection fluid. However, no consumer complaints or injuries related to the injection fluid have been reported to date.

Particulate matter in injection fluids can cause serious adverse health consequences to patients depending on the severity of their condition. Patients may experience mild symptom of nausea to more severe and life threatening side affects, depending upon the amount and size of particulate matter injected.

The recalled Vistide cidofovir injection is a sterile fluid that is administered intravenously to treat cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome (AIDS). The injection is usually given in a hospital or a doctor’s office.

The Vistide fluid was manufactured by Gilead Sciences of Foster City, California and distributed to wholesalers, hospitals, and retail pharmacies all across the United States, Canada, and Europe. The recalled Vistide has a NDC number 61958-0101-1 and Lot number B120217A with an expiration date of May 2015. The recalled lot number can be located on a label on the side of the vial.

Gilead Sciences has initiated contacting its distributors by mail and email to notify them of the recall and to discontinue use and isolate the product so it can be returned by calling Stericycle at 1-888-965-5791.

Healthcare professionals and patients are also encouraged to complete and submit the report online at www.fda.gov/MedWatch/report.htm and download “Form 2” or call 1-800-332-1088 to request a reporting form to be completed and returned to the pre-addressed, or submit by fax at 1-800-FDA-0178. Patients should also contact their physician or healthcare provider if they have experienced any abnormal side effects that may be related to the use of a tainted Vistide injection fluid.