January 2013 FDA Recall Drug by Gilead Sciences, Inc.
D-324-2013 - Presence of Particulate Matter

This Class I drug recall was voluntarily initiated by Gilead Sciences, Inc. on January 31, 2013 for the product Drug. The FDA reported the reason for recall as presence of particulate matter. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-324-2013

Reason for Recall
Presence of Particulate Matter: Particulate matter was found in some vials of Vistide (cidofovir injection).
Initiated
01-31-2013
Reported
05-22-2013
Quantity
3,181 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
64267
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Gilead Sciences, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide in USA, Canada, and UK (Gilead facility in Cork Ireland). Cork facility distributed to Germany/Austria, Italy and Spain.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-06-2014
Product Description About Product Description
Full technical description of the product.
Vistide (cidofovir) Injection, 375 mg (75 mg/mL), 5 mL single-use vial, Rx only, Manufactured for: Gilead Sciences, Inc., Foster City, CA 94404, UPC 3 61958 01011 5; NDC 61958-0101-1.

Batch or Lot Expiration Information

Lot# : B120217A, Exp 05/15 - US Distribution