Status
Terminated
Drug Enforcement D-932-2013
Presence of Particulate Matter: Visible particulate embedded in the glass vial was observed and confirmed in a sample bottle during retain sample inspection.
Classification
Class II
Report Date
September 18, 2013
Termination Date
September 18, 2014
Product Information
- Product description
- Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), packaged in 5 Units x 20 mL Single patient infusion vials per carton, Rx only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-4699-30
- Product quantity
- 283,150 vials
- Reason for recall
- Presence of Particulate Matter: Visible particulate embedded in the glass vial was observed and confirmed in a sample bottle during retain sample inspection.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- Hospira Inc.
- Address
-
275 N Field Dr, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-932-2013
- Event ID
- 66134
- Recall initiation date
- August 14, 2013
- Center classification date
- September 9, 2013
- Code info
- Lot #: 24-461-DJ*, Exp 12/14; 26-543-DJ*, Exp 02/15; 27-555-DJ*, 27-559-DJ*, Exp 03/15; *lot number may be followed by 01
- More code info
- —