Reported Apr 3, 2013 · Terminated
Propofol Injectable Emulsion, 1%, packaged in a) 5 x 20 mL Single patient infusion vials per carton, 200 mg/20 mL (10…
Hospira Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Hospira Inc. · 275 N Field Dr · Lake Forest, IL · 60045-2579
Is this the product you have?
- 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.
- Lot codes and dates
- 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.
- Amount recalled
- 68,020 vials
Where it was sold
- Nationwide
Why it was recalled
Presence of Particulate Matter: Visible particulate embedded in vials was observed and confirmed in a sample bottle during retain inspection.
This product could cause temporary or reversible health problems — stop using it.
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