Severity
Critical
CriticalClass ITerminated
FDA Drug recall · Reported February 25, 2015
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.
Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
Hospira Inc. recalled Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL Single patient infusion … - a critical-severity action.
Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL Single patient infusion … was recalled by Hospira Inc. in February 25, 2015. Reason: Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.. Check the official notice for the remedy. Verify recall #D-0389-2015 with the FDA Drug before acting.
The recall
Hospira Inc. issued this critical-severity FDA Drug recall-Temperature Abuse: Products experienced uncontrolled temperature excursions during transit..
- Critical
- severity level
- Class I
- classification
- February 25, 2015
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0389-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0389-2015) was formally reported on February 25, 2015, with the manufacturer initiating the action on October 6, 2014. It is classified under Critical severity (Class I), with a current status of Terminated. Hospira Inc. is listed as the recalling firm, operating out of Lake Forest, IL. Federal records list the affected scope as 2,500 vials.
The documented reason for this recall is: Temperature Abuse: Products experienced uncontrolled temperature excursions during transit. Distribution data in the federal record shows the product reached: 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 w…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
2,500 vials
Related Recalls
6
0 from same agency
Product description
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.
Reason for recall
Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | D-0389-2015 |
| Date reported | February 25, 2015 |
| Date initiated | October 6, 2014 |
| Recalling firm | Hospira Inc. |
| Firm location | Lake Forest, IL |
| Affected scope | 2,500 vials |
| Distribution | 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… |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-0389-2015) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Hospira Inc.. Units affected: 2,500 vials.
Why was this product recalled? ▼
Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 25, 2015. Severity: Critical. Recall number: D-0389-2015.
Where was the recalled product distributed? ▼
Distribution: 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..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0389-2015) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported February 25, 2015. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.