CLASS II Drug recall · Reported 4 Feb 2015 · FDA Enforcement Report
Propofol Injectable Emulsion, 1%, 200 mg/, (10mg/mL) recalled by Hospira
Hospira is recalling Propofol Injectable Emulsion, 1%, 200 mg/, (10mg/mL), Single patient infusion vial, distributed nationwide in the US. The recall was initiated on 23 Dec 2014 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-0381-2015
- FDA event ID
- 70179
- Recalling firm
- Hospira, Lake Forest, IL
- Brand
- Propofol
- Manufacturer
- Hospira, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 Dec 2014
- FDA classified
- 27 Jan 2015
- Reported
- 4 Feb 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Particulate Matter
- Drug class
- Injectable & IV Drugs
Timeline
| 23 Dec 2014 | Recall initiated by company | |
| 27 Jan 2015 | Classified by FDA | +35 days |
| 4 Feb 2015 | Published in enforcement report | +8 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: The firm received a complaint of an embedded particulate in the neck of one vial composed primarily of iron.
Product as listed by the FDA
Propofol Injectable Emulsion, 1%, 200 mg/20 mL, (10mg/mL), 20 mL, Single patient infusion vial, Contains Benzyl Alcohol, For I.V. Administration, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-30
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Presence of Particulate Matter: The firm received a complaint of an embedded particulate in the neck of one vial composed primarily of iron.
Which lots are affected?
Lot 35-844-DJ, Exp 11/01/2015
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 26 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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| Drug | CLASS II | Fentanyl Citrate Injection, USP, 100 mcg Fentanyl recalled by Hospira | Hospira | Sterility | Nationwide |
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Other Propofol recalls
All 19| 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 | Propofol Injectable Emulsion, USP 200 mg per (10 mg per mL) recalled | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Propofol Injectable Emulsion, USP, 200 mg/ (10 mg/mL) recalled | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Diprivan (Propofol) Emulsion, 100 mg/mL vial recalledDiprivan | Mckesson Medical-Surgical Inc. Corporate Office | Manufacturing (CGMP) Deviations | Nationwide |