Pharmaceutical Processing World

  • Home
  • Regulatory
    • Recalls
  • Pharmaceutical Processing
  • Facility
  • Supply Chain
  • Equipment and Materials
  • Contract Manufacturing
  • Resources
    • Voices
  • Advertise
  • SUBSCRIBE

Gilead Issues a Voluntary Recall of One Lot of Vistide® (Cidofovir Injection) Due to Presence of Particulate Matter

By Pharmaceutical Processing | February 19, 2013

Gilead Sciences, Inc. has 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.

Gilead has notified its distributors and customers by e-mail and recall letter and is arranging for return of all recalled product.

In the United States, for information on how to return Vistide product with lot number B120217A, call Stericycle at 1-888-965-5791, Monday to Friday 8:00 a.m. to 8:00 p.m. Eastern Time.

Before injecting Vistide, the product should be inspected and any product with lot number B120217A should not be injected.

Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to using Vistide. Healthcare professionals and pharmacists with questions regarding this recall can contact Gilead Medical Information at 1-800-GILEAD-5 (1-800-445-3235) [Option 2], Monday to Friday 8:00 a.m. to 5:00 p.m. Pacific Time.

Adverse reactions or quality problems experienced with the use of this product may be reported to Gilead Medical Information at 1-800-GILEAD-5 (1-800-445-3235) [Option 2], Monday to Friday 8:00 a.m. to 5:00 p.m. Pacific Time.

Adverse reactions can also be reported directly to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax:

Online: www.fda.gov/medwatch/report.htm

Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form.

Fax: 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

 

Related Articles Read More >

kobayashi pharmaceutical logo
Report: Japan health authorities investigate Kobayashi Pharmaceutical factory after five deaths
Disposable syringe and American currency on black background
PBMs increasingly under fire in drug-pricing battle
Johnson & Johnson logo
Timeline: Navigating Johnson & Johnson’s talc lawsuits and their stock performance impact
pharmaceutical industry. Production line machine conveyor with glass bottles ampoules at factory
5 core trends in drug recalls: An analysis of 2022 and Q1 2023
“ppw
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest news, technologies, and developments in Pharmaceutical Processing.

DeviceTalks Tuesdays

DeviceTalks Tuesdays

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
Pharmaceutical Processing World
  • Subscribe to our E-Newsletter
  • Contact Us
  • About Us
  • R&D World
  • Drug Delivery Business News
  • Drug Discovery & Development
  • DeviceTalks
  • MassDevice
  • Medical Design & Outsourcing
  • MEDICAL TUBING + EXTRUSION
  • Medical Design Sourcing
  • Medtech100 Index
  • R&D 100 Awards

Copyright © 2025 WTWH Media LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media
Privacy Policy | Advertising | About Us

Search Pharmaceutical Processing World

  • Home
  • Regulatory
    • Recalls
  • Pharmaceutical Processing
  • Facility
  • Supply Chain
  • Equipment and Materials
  • Contract Manufacturing
  • Resources
    • Voices
  • Advertise
  • SUBSCRIBE