Dobutamine Injection Recalled for Visible Contamination

May 16, 2014 — Hospira Inc. has issued a recall for dobutamine injections that were after finding contamination and/or a glass defect in the vial.

Recalled injections include:

• Dobutamine injection USP, 250 mg, 20 mL, Single-dose fliptop vial, (NDC 0409-2344-02), Lot 27-352-DK. (NDC and lot number can be found on the right-hand side of the primary label). Distributed from August until September 2013.

The recall was issued after one customer reported a discolored solution. Upon close investigation, a chip in the glass at the neck of the vial was identified as well as particles of glass in the solution. The discoloration may have resulted from contamination or oxidation.

Health Risks

The U.S. Food and Drug Administration (FDA) warned that contaminated injections may cause severe adverse events. Particulate matter in an injection could cause local inflammation, phlebitis (vein inflammation), obstruction of small capillaries, and possibly granuloma formation in the lungs.

If the vial is not sterile, injection of a contaminated solution can potentially cause bacteremia, sepsis, septic shock, endocarditis, multi-system organ failure, and death. Symptoms of this reaction may include:

• Redness, pain, and swelling at the injection site
• Fever
• Shortness of breath
• Tachycardia (racing, irregular heartbeat)
• Nausea, vomiting

What is Dobutamine?

Dobutamine is an injection medication that is used to improve heart function. It is typically given intravenously or with a catheter over 12 hours every other day. It strengthens the heart muscle and helps relieve symptoms of heart failure. Severe side effects include abnormal heart rhythm, high blood pressure, shortness of breath, chest pain, edema, and more.

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