Reported Feb 20, 2013 · Terminated

Propofol Injectable Emulsion, 1%, packaged in a) 20 mL Single patient infusion vial, 200 mg/20 mL (10 mg/mL), NDC…

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?

3 of 3 products

Products covered by this recall
#Product as published
120 mL Single patient infusion vial, 200 mg/20 mL (10 mg/mL), NDC 0409-4699-30
250 mL Single patient infusion vial, 500 mg/50 mL (10 mg/mL), NDC 0409-4699-33
3100 mL Single patient infusion vial, 1 g/100 mL (10 mg/mL), NDC 0409-4699-24; Rx only, Hospira, Inc., Lake Forest, IL 60045 USA
Lot codes and dates

3 of 3 products

Products covered by this recall
#Product as published
195-070-DJ, Exp 11/01/12; 04-584-DJ, 04-652-DJ, Exp 04/01/13; 05-718-DJ, Exp 05/01/13; 06-815-DJ, Exp 06/01/13
204-525-DJ, 04-530-DJ, 04-641-DJ-04-646-DJ, Exp 04/01/13
302-291-DJ, Exp 02/01/13; 05-725-DJ, 05-732-DJ, Exp 05/01/13; 07-925-DJ, Exp 07/01/13; 09-065-DJ, Exp 09/01/13; 10-129-DJ, 10-133-DJ, 10-148-DJ, Exp 10/01/13, Note lot number may be followed by 01.
Amount recalled
273,925 vials

Where it was sold

  • Nationwide

Why it was recalled

Presence of Particulate Matter: Visible particulate and particulate embedded in vials were observed during retain inspection.

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 Feb 27, 2014 · Data as of Sep 19, 5:36 PM UTC

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