Drug recall D-324-2013

Class I Terminated reported May 22, 2013

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.

Reason for recall

Presence of Particulate Matter: Particulate matter was found in some vials of Vistide (cidofovir injection).

Lots and codes

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

Recall details

Recalling firm
Gilead Sciences, Inc., Foster City, CA
Quantity
3,181 vials
Distribution
Nationwide in USA, Canada, and UK (Gilead facility in Cork Ireland). Cork facility distributed to Germany/Austria, Italy and Spain.
Type
Voluntary: Firm initiated
Recall initiated
January 31, 2013
Terminated
January 6, 2014