Hospira Issues Voluntary Recall of Dobutamine Due to Visible Particulates

Hospira, Inc. issued a press release on May 14, 2014, to report that on January 10, 2014, it issued a nationwide recall to the user level for one lot of the cardiovascular drug, dobutamine Injection, USP, 250 mg, 20 mL, single-dose fliptop vial, (NDC 0409-2344-02), Lot 27-352-DK. The recall was due to a confirmed customer report of discolored solution. Upon review of the complaint, a chip in the glass at the neck of the vial was identified as well as glass particulate within the solution. The discoloration of the solution may have resulted either from contamination of the solution or more likely, oxidation, as dobutamine is oxygen-sensitive, according to the company. To date, Hospira has not received reports of any adverse events associated with this issue for this lot.

This lot was distributed nationwide to distributors/wholesalers, hospitals, and clinics from August 2013 through September 2013. Hospira was unable to determine the root cause, but recalled the entire lot as a precautionary measure. The issue wasn’t found in any retained samples from the lot.

Risk factors associated with particulate and/or a glass defect include the potential for particulate to be injected, a breach of sterility/contamination of the vial contents, leakage of contents, and/or a delay in therapy.

In general, injected particulate matter may result acutely in local inflammation, phlebitis, and/or low level allergic response through mechanical disruption of tissue or immune response to the particulate. Small capillaries may become obstructed. Chronically, following sequestration, some granuloma formation in the lungs is possible. A loss of sterility is a primary concern when a container has a leak because 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. Leakage may result in drug wastage, spillage onto equipment, flooring, and personnel. 

Source: Hospira


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