CLASS I Drug recall · Reported 25 Feb 2015 · 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 vials, distributed nationwide in the US. The recall was initiated on 6 Oct 2014 and the FDA has classified it as Class I.
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-0389-2015
- FDA event ID
- 69573
- Recalling firm
- Hospira, Lake Forest, IL
- Brand
- Propofol
- Manufacturer
- Hospira, Inc.
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 6 Oct 2014
- FDA classified
- 13 Feb 2015
- Reported
- 25 Feb 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Packaging Defects
- Drug class
- Injectable & IV Drugs
Timeline
| 6 Oct 2014 | Recall initiated by company | |
| 13 Feb 2015 | Classified by FDA | +130 days |
| 25 Feb 2015 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL Single patient infusion vials, packaged in 5 Units per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-30.
Where it was distributed
Distribution limited to one shipment to The Harvard Drug Group, Livonia, MI for the lots of Vancomycin 500 mg, Ketorolac tromethamine 60 mg/2 mL (30 mg/mL), and Propofol 1% 200 mg/20 mL (10 mg/mL), these lots remained within the control of the distributor and were not further distributed. Distribution was Nationwide for the Vancomycin 1 g product.
Questions about this recall
Why was it recalled?
Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.
Which lots are affected?
One shipment of Lot #: 33-750-DJ; Exp 1SEP2015 to The Harvard Drug Group, Livonia, MI
Where was it sold?
Distribution limited to one shipment to The Harvard Drug Group, Livonia, MI for the lots of Vancomycin 500 mg, Ketorolac tromethamine 60 mg/2 mL (30 mg/mL), and Propofol 1% 200 mg/20 mL (10 mg/mL), these lots remained within the control of the distributor and were not further distributed. Distribution was Nationwide for the Vancomycin 1 g product.
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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
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.
Other products in this recall event
3 other products · FDA event 69573| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Ketorolac Tromethamine Inj., USP, 60 mg recalled by HospiraKetorolac Tromethamine | Hospira | Packaging Defects | Nationwide | |
| CLASS II | Vancomycin Hydrochloride for Injection recalled by HospiraVancomycin Hydrochloride | Hospira | Sterility | Nationwide | |
| CLASS II | Vancomycin Hydrochloride for Injection recalled by HospiraVancomycin Hydrochloride | Hospira | Sterility | Nationwide |
More recalls from Hospira
All 225| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Infant 25% Dextrose Injection recalled by HospiraDextrose | Hospira | Particulate Matter | Nationwide |
| Device | CLASS II | Minibore Extension Set with Spin Lock Collar, Non-DEHP, Latex-Free recalled | Hospira | Other | Nationwide |
| Drug | CLASS III | 5% Lidocaine HCL and 7.5% Dextrose Injection, USP Single-dose ampule recalled | Hospira | Potency & Assay | PR |
| Drug | CLASS II | Fentanyl Citrate Injection, USP, 100 mcg Fentanyl recalled by Hospira | Hospira | Sterility | Nationwide |
| Device | CLASS II | LifeCare PCA 3, PCA recalled by Hospira | Hospira | Device Malfunction | Nationwide |
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 II | Propofol Injectable Emulsion, 1%, 200 mg/, (10mg/mL) recalled by HospiraPropofol | Hospira | Particulate Matter | Nationwide |