FDA Recall D-324-2013
Gilead Sciences, Inc. · Foster City, CA
Class I — life-threatening Terminated 340 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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).
Recall record
- Recall number
D-324-2013- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Distribution
- Nationwide in USA, Canada, and UK (Gilead facility in Cork Ireland). Cork facility distributed to Germany/Austria, Italy and Spain.
- Recall initiated
- 2013-01-31
- Classified by FDA Center
- 2013-05-16
- FDA published
- 2013-05-22
- Terminated
- 2014-01-06
- Recalling firm
- Gilead Sciences, Inc.
- Firm location
- Foster City, CA