FDA recall D-324-2013

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).

Distribution

Nationwide in USA, Canada, and UK (Gilead facility in Cork Ireland). Cork facility distributed to Germany/Austria, Italy and Spain.

Key facts

Status

Terminated

Initiation date

2013-01-31

Report date

2013-05-22

Termination date

2014-01-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Foster City, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-324-2013