Status
Terminated
Drug Enforcement D-324-2013
Presence of Particulate Matter: Particulate matter was found in some vials of Vistide (cidofovir injection).
Classification
Class I
Report Date
May 22, 2013
Termination Date
January 6, 2014
Product Information
- 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.
- Product quantity
- 3,181 vials
- Reason for recall
- Presence of Particulate Matter: Particulate matter was found in some vials of Vistide (cidofovir injection).
- Recall initiation reason
- —
- Initial firm notification
- Distribution pattern
- Nationwide in USA, Canada, and UK (Gilead facility in Cork Ireland). Cork facility distributed to Germany/Austria, Italy and Spain.
Location & Firm
- Recalling firm
- Gilead Sciences, Inc.
- Address
-
333 Lakeside Drive
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-324-2013
- Event ID
- 64267
- Recall initiation date
- January 31, 2013
- Center classification date
- May 16, 2013
- Code info
- Lot #: B120217A, Exp 05/15 - US Distribution
- More code info
- —