May 16, 2014 — Hospira Inc. and the U.S. Food and Drug Administration (FDA) are recalling one lot of dobutamine injections because they may be contaminated, non-sterile, and/or have a defect in the glass vial that could result in particles of glass in the solution.
Product recalled:
- Dobutamine injection USP, 250 mg, 20 mL, Single-dose fliptop vial, (NDC 0409-2344-02), Lot 27-352-DK.
The NDC and lot number can be found on the right-hand side of the primary label. The injections were distributed from August until September 2013. Dobutamine is administered intravenously to strengthen the heart muscle of patients with heart failure.
The problem was discovered when a customer noticed a discolored solution. Further inspection revealed chipped glass in the neck of the vial and visible particles of glass.
Health Risks
Although the cause of the problem was not discovered, the discoloration may have been due to loss of sterility or oxidation. The FDA warned that an injection of particulates in dobutamine could cause local inflammation, vein inflammation (phlebitis), obstruction of small capillaries, and more.
Injection of a non-sterile medicine could cause a severe infection or inflammatory reaction that could cause multi-organ system failure and death. The FDA warned:
“A loss of sterility is a primary concern when a container has a leak, since an open pathway exists for contamination of fluid. If contaminated solution is used on a patient, this may potentially cause bacteremia, sepsis, septic shock and endocarditis, and death may result.”
Symptoms of these complications include:
- Redness, pain, and swelling at the injection site
- Fever
- Shortness of breath
- Tachycardia (racing, irregular heartbeat)
- Nausea, vomiting
Do I have a Hospital Infection Lawsuit?
The Schmidt Firm, PLLC is currently accepting hospital infection induced injury cases in all 50 states. If you or somebody you know has been injured by contaminated dobutamine injections, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Drug Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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