Recalls / Class I
Class ID-324-2013
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences 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.
- Affected lot / code info
- Lot #: B120217A, Exp 05/15 - US Distribution
Why it was recalled
Presence of Particulate Matter: Particulate matter was found in some vials of Vistide (cidofovir injection).
Recalling firm
- Firm
- Gilead Sciences, Inc.
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 333 Lakeside Drive, Foster City, California 94404-1147
Distribution
- Quantity
- 3,181 vials
- Distribution pattern
- Nationwide in USA, Canada, and UK (Gilead facility in Cork Ireland). Cork facility distributed to Germany/Austria, Italy and Spain.
Timeline
- Recall initiated
- 2013-01-31
- FDA classified
- 2013-05-16
- Posted by FDA
- 2013-05-22
- Terminated
- 2014-01-06
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-324-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.