FDAFDA · Food and drugs·Recall number D-1382-2012
Propofol Injectable Emulsion, 1%, (10mg/mL), packaged in a) 200 mg/20 mL, 5 Units x 20 mL Single patient infusion vials per carton (NDC 0409-4699-30); b) 1 g/100 mL, 10 Units x 100 mL Single patient infusion vials per carton (NDC 0409-4699-24); Rx only, Hospira, Inc., Lake Forest, IL 60045, USA.
Published June 20, 2012 · Recall initiated: April 11, 2012
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: A single visible particulate was observed in a retention sample bottles identified as stainless steel
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- PROPOFOL
- Manufacturer
- Hospira, Inc.
- Distributor
- Nationwide.
- Lot
- Lot #: a) 03440DJ*, Exp 1MAR2013; b) 07947DJ, Exp 1JUL2013; 10134DJ, Exp 1OCT2013; Note: * the lot may be followed by 01.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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