Hospira Recalls Bupivacaine Hydrochloride Injection, USP

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The company is voluntarily recalling one lot of product due to particulate matter.

On August 5, 2016, Hospira voluntarily recalled one lot of 0.25% Bupivacaine Hydrochloride Injection, USP (NDC: 0409-1159-02, Lot 59-064- DK, Expiry 1NOV2017) because of a customer complaint of particulate matter found in a single vial. The recalled lot, which is packaged in 50 units of 30 mL single-use teartop vials per case, was distributed nationwide in the United States between December 2015 and January 2016. The company is performing an investigation to determine root cause of the particulate contamination and states it will establish corrective actions and preventive actions.

Hospira has not yet received any reports of adverse events associated with the recalled lot. According to the company, “in the event that the particulate is administered to a patient, it may result in local swelling, irritation of bloodvessels or tissue, blockage of blood vessels, and/or low-level allergic response to the particulate.”

Adverse events may be reported to FDA by visiting www.fda.gov/medwatch/report.htm.


Source: FDA