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Gilead Issues A Voluntary Recall Of One Lot Of Vistide® (Cidofovir Injection) Due To Presence Of Particulate Matter

Gilead Sciences, Inc. (Nasdaq: GILD) today announced it is voluntarily recalling lot B120217A of Vistide ® (cidofovir injection) to the user level due to the presence of particulate matter found in some vials of this lot.
Product Description NDC Lot # Expiration Date
Vistide ®

(cidofovir injection)
61958-0101-1 B120217A May 2015

Effects from intravenous injection of product with particulate matter can vary depending on the amount of particulate matter injected into the patient, the size of the particles and the patient’s underlying medical condition, and can be severe. Gilead is not currently aware of any complaint attributable to the particles.

Vistide is indicated for the treatment of cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome (AIDS). Vistide is a sterile, hypertonic aqueous solution for intravenous infusion only. The solution is clear, colorless and supplied in clear glass vials. It is typically given in a hospital setting or in a doctor’s office. The lot number, located on the product label on the side of the vial, is B120217A. This lot of Vistide was distributed in the United States, Canada and Europe to wholesalers and hospital and retail pharmacies. The recall does not affect any other Gilead products.

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