Class II · Moderate risk
DOBUTamine Injection
Discoloration; discolored solution from cracked vials
DOBUTamine in 5% Dextrose Injection (Dobutamine in Dextrose)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility: Confirmed report of leaking in the primary container.
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
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
Affected NDC
0409-2346-32
Compare with the code on your package — it is the most precise check available.
Drug: Dobutamine
- Recalling firm
- Hospira Inc.
- NDC code
- 0409-2346-32
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-502-2013 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Dobutamine recalls
See all
Class II · Moderate risk
Dobutamine
Lack of sterility assurance
Class II · Moderate risk
DOBUTamine Injection
Discoloration: Firm received complaints of product discoloration and particulates.
Class II · Moderate risk
Dobutamine 2000 mcg/mL in a) D5W-500 mL
Lack of Sterility Assurance.
Class II · Moderate risk
DOBUTAMINE HCL in D5W
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Other recalls by Hospira Inc.
All 2013 recalls
Class I · High risk
Infant 25% DEXTROSE Injection
Presence of Particulate Matter: human hair found within an internal sample syringe.
Class II · Moderate risk
Fentanyl Citrate Injection
Lack of Assurance of Sterility: Complaints of broken tips on the ampules.
Class II · Moderate risk
DOBUTamine Injection
Discoloration: Firm received complaints of product discoloration and particulates.
Class III · Low risk
5% Lidocaine HCL and 7.5% Dextrose Injection
Failed Stability Specifications: The recalled lots did not meet the specification for color and pH throughout shelf life.
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