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FDA Reports Voluntary Recall of Bupivacaine Hydrochloride Injection

Aug 16, 2016

On August 5, 2016, Hospira, a Pfizer pharmaceutical company based in Lake Forest Illinois, voluntarily recalled one lot of product as a result of particulate matter found in one vial. The affected product is 0.25 percent Bupivacaine Hydrochloride Injection packaged in 50 units of 30 mL single-use teartop vials per case. The product was distributed nationwide in the United States between December 2015 and January 2016.

Hospira is performing an investigation to determine the cause of the contamination and states that it will establish corrective and preventive actions. According to Hospira, "in the event that the particulate is administered to a patient, it may result in local swelling, irritation of blood vessels or tissue, blockage of blood vessel, and/or low-level allergic response to the particulate."

The 0.25 percent Bupivacaine Hydrochloride Injection is used in the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures, according to the U.S. Food and Drug Administration (FDA).

A label clearly advising doctors to visually inspect the product for particulate matter and discoloration before it is administered, reduces the possibility of risk. Currently, no reports of any adverse reaction associated with the product have been received.

Hospira puts the highest emphasis on product quality and patient safety at every point in the manufacturing and supply process. Customers will be notified by letter and Hospira is arranging for the affected product to be returned to Stericycle in the United States.

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