Drug 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.
D-324-2013
Product summary
- Event
- Event 64267
- Status
- Terminated
- Classification
- Class I
- Quantity
- 3,181 vials
- Official record key
drug-enforcement:D-324-2013
Official wording
Reason: Presence of Particulate Matter: Particulate matter was found in some vials of Vistide (cidofovir injection).
Code information: Lot #: B120217A, Exp 05/15 - US Distribution
Distribution pattern: Nationwide in USA, Canada, and UK (Gilead facility in Cork Ireland). Cork facility distributed to Germany/Austria, Italy and Spain.
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter