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.
Reported: May 22, 2013 Initiated: January 31, 2013 #D-324-2013
Product Description
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).
Details
- Recalling Firm
- Gilead Sciences, Inc.
- Units Affected
- 3,181 vials
- Distribution
- Nationwide in USA, Canada, and UK (Gilead facility in Cork Ireland). Cork facility distributed to Germany/Austria, Italy and Spain.
- Location
- Foster City, CA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Gilead Sciences, Inc.. Units affected: 3,181 vials.
Why was this product recalled? ▼
Presence of Particulate Matter: Particulate matter was found in some vials of Vistide (cidofovir injection).
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 22, 2013. Severity: Critical. Recall number: D-324-2013.
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