In the announcement of a voluntary recall by Gilead Sciences of Foster City, California, the U.S. Food and Drug Administration (FDA) indicated that "particulate matter" had been discovered in some vials of one lot of cidofovir (Vistide) for intravenous infusion. Vistide is used to treat cytomegalovirus (CMV) retinitis (eye infection) in AIDS patients.
According to a recent article in MedPage Today, at this time it is not clear whether the particulate matter is contamination or a crystallized component of the medicine. Gilead has not received any reports of patient injuries due to this problem, but it is believed that "the particles… could have adverse effects," according to Gilead.
The lot being recalled is identified as "lot number B120217A" distributed in the United States, Canada and in Europe to pharmacies and medical wholesalers. The Company is in the process of notifying distributors and customers via email, and is urging patients and physicians to examine all vials of cidofovir prior to giving the medicine to patients.
Physicians, caregivers or patients with the affected lot number B1202171A vial(s) of cidofovir should contact Gilead Medical Information by calling 1-888-445-3235, weekdays from 8:00 a.m. until 4:30 p.m. Pacific Time to arrange for return of the recalled medicine.
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