CLASS II Drug recall · Reported 1 May 2013 · FDA Enforcement Report
Propofol Injectable Emulsion, 1%, 200 mg recalled by Hospira
Hospira is recalling Propofol Injectable Emulsion, 1%, 200 mg/ (10 mg/mL) Single patient infusion vial, distributed nationwide in the US. The recall was initiated on 8 Apr 2013 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-297-2013
- FDA event ID
- 64990
- Recalling firm
- Hospira, Lake Forest, IL
- Brand
- Propofol
- Manufacturer
- Hospira, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 8 Apr 2013
- FDA classified
- 24 Apr 2013
- Reported
- 1 May 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 8 Apr 2013 | Recall initiated by company | |
| 24 Apr 2013 | Classified by FDA | +16 days |
| 1 May 2013 | Published in enforcement report | +7 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 identified during a retain sample inspection.
Product as listed by the FDA
Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL Single patient infusion vial, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-30.
Where it was distributed
Nationwide and Puerto Rico
Questions about this recall
Is Propofol Injectable Emulsion, 1%, 200 mg/ (10 mg/mL) Single patient infusion vial recalled?
Yes. Hospira recalled Propofol Injectable Emulsion, 1%, 200 mg/ (10 mg/mL) Single patient infusion vial on 8 Apr 2013. The recall is Class II and its status is Terminated. Recall number D-297-2013.
Why was it recalled?
Presence of Particulate Matter: A single visible particulate was identified during a retain sample inspection.
Which lots are affected?
Lot #: 11-185-DJ*, 11-196-DJ*, Exp 1NOV2013; * may be followed by 01 or 02
Where was it sold?
Nationwide and Puerto Rico
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 |