D-324-2013 Class I Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- May 22, 2013
- Initiation Date
- January 31, 2013
- Termination Date
- January 6, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,181 vials
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).
Distribution Pattern
Nationwide in USA, Canada, and UK (Gilead facility in Cork Ireland). Cork facility distributed to Germany/Austria, Italy and Spain.
Code Information
Lot #: B120217A, Exp 05/15 - US Distribution