CLASS II Drug recall · Reported 5 Sep 2012 · FDA Enforcement Report
Propofol Injectable Emulsion recalled by Hospira
Hospira is recalling Propofol Injectable Emulsion, 1% (10 mg/mL) Single patient infusion vial, distributed nationwide in the US. The recall was initiated on 3 Aug 2012 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1672-2012
- FDA event ID
- 62999
- Recalling firm
- Hospira, Lake Forest, IL
- Brand
- Propofol
- Manufacturer
- Hospira, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 3 Aug 2012
- FDA classified
- 30 Aug 2012
- Reported
- 5 Sep 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 3 Aug 2012 | Recall initiated by company | |
| 30 Aug 2012 | Classified by FDA | +27 days |
| 5 Sep 2012 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Particulate Matter: A single visible particulate was observed and confirmed in a sample bottle during retain inspection.
Product as listed by the FDA
Propofol Injectable Emulsion, 1%, 1 g/100 mL (10 mg/mL), 100 ml Single patient infusion vial, Rx only, Hospira, Inc. Lake Forest, IL 60045 USA, NDC 0409-4699-24
Where it was distributed
Nationwide
Questions about this recall
Is Propofol Injectable Emulsion, 1% (10 mg/mL) Single patient infusion vial recalled?
Yes. Hospira recalled Propofol Injectable Emulsion, 1% (10 mg/mL) Single patient infusion vial on 3 Aug 2012. The recall is Class II and its status is Terminated. Recall number D-1672-2012.
Why was it recalled?
Presence of Particulate Matter: A single visible particulate was observed and confirmed in a sample bottle during retain inspection.
Which lots are affected?
07-893-DJ, exp. 7/2013, 10-123-DJ, 10-125-DJ, exp. 10/2013
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Propofol recalls
All 17| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Propofol Injectable Emulsion (10 mg/mL) recalled by PfizerPropofol | Pfizer | Particulate Matter | Nationwide |
| Drug | CLASS I | Propofol Injectable Emulsion (10 mg/mL) recalled by PfizerPropofol | Pfizer | Particulate Matter | Nationwide |
| Drug | CLASS II | Diprivan (Propofol) Emulsion, 100 mg/mL vial recalledDiprivan | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Diprivan (Propofol) Emulsion, 200 mg per (10mg/mL) vial recalledDiprivan | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS I | Propofol Injectable Emulsion, 1%, 200 mg recalled by HospiraPropofol | Hospira | Packaging Defects | Nationwide |