FDAFDA · Food and drugs·Recall number D-223-2013
Propofol Injectable Emulsion, 1%, packaged in a) 5 x 20 mL Single patient infusion vials per carton, 200 mg/20 mL (10 mg/mL), NDC 0409-4699-30; b) 10 x 100 mL Single patient infusion vials per carton, 1 g/100 mL (10 mg/mL), NDC 0409-4699-24; Rx only, Hospira, Inc., Lake Forest, IL 60045 USA.
Published April 3, 2013 · Recall initiated: February 25, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Presence of Particulate Matter: Visible particulate embedded in vials was observed and confirmed in a sample bottle during retain inspection.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- PROPOFOL
- Manufacturer
- Hospira Inc.
- Distributor
- Nationwide.
- Lot
- a) Lot #: 06-804-DJ*, Exp 1JUN2013; and b) Lot #: 05-736-DJ*, Exp 1MAY2013; 09-066-DJ*, Exp 1SEP2013. *Note: the lot number may be followed by 01 or 02.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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