CLASS II Drug recall · Reported 12 Jun 2013 · FDA Enforcement Report
DOBUTamine in 5% Dextrose Injection, USP, 250 mg Total, 1000 mcg/mL recalled
Hospira is recalling DOBUTamine in 5% Dextrose Injection, USP, 250 mg Total, 1000 mcg/mL, distributed nationwide in the US. The recall was initiated on 30 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-502-2013
- FDA event ID
- 65225
- Recalling firm
- Hospira, Lake Forest, IL
- Manufacturer
- Hospira, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 30 Apr 2013
- FDA classified
- 3 Jun 2013
- Reported
- 12 Jun 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 30 Apr 2013 | Recall initiated by company | |
| 3 Jun 2013 | Classified by FDA | +34 days |
| 12 Jun 2013 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility: Confirmed report of leaking in the primary container.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
DOBUTamine in 5% Dextrose Injection, USP, 250 mg Total, 1000 mcg/mL 250 mL bag, Rx only, HOPIRA, INC., LAKE FOREST, IL 60045 NDC 0409-2346-32
Where it was distributed
Nationwide and Puerto Rico
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility: Confirmed report of leaking in the primary container.
Which lots are affected?
Lot 11-309-KL
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 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.
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 Dobutamine recalls
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | DOBUTamine Injection, USP, 250 mg recalled by PfizerDobutamine | Pfizer | Other | Nationwide |
| Drug | CLASS II | Dobutamine, (a) 1080MG IN D5W, (b) 760MG IN D5W, ionotrop recalled | Sentara Infusion Services | Sterility | Nationwide |
| Drug | CLASS II | DOBUTamine Injection, USP 250 mg/ Vial, For IV Use Only recalled | Hospira | Particulate Matter | Nationwide |
| Drug | CLASS II | Dobutamine 2000 mcg/mL in a) D5W-, b) D5W-, c) D5W recalled | Baptist Health Medical Towers Pharmacy and Infusion Services | Sterility | AR |
| Drug | CLASS II | Dobutamine HCL in D5W, Packaged as a) 240MG in Homepumps recalled | Sentara Enterprises | Sterility | NC, VA |