Reported Jun 20, 2012 · Terminated

Propofol Injectable Emulsion, 1%, (10mg/mL), packaged in a) 200 mg/20 mL, 5 Units x 20 mL Single patient infusion vials…

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. · 600 N Field Dr Bldg J45 · Lake Forest, IL · 60045

Is this the product you have?

  • 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.
Lot codes and dates
    • Lot #: a) 03440DJ*
    • Exp 1MAR2013
    • b) 07947DJ
    • Exp 1JUL2013
    • 10134DJ
    • Exp 1OCT2013
  • Note* the lot may be followed by 01
Amount recalled
a) 36,125 vials; b) 31,280 vials

Where it was sold

  • Nationwide

Why it was recalled

Presence of Particulate Matter: A single visible particulate was observed in a retention sample bottles identified as stainless steel

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Jun 27, 2013 · Data as of Sep 19, 7:05 PM UTC

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