Pfizer’s Hospira Recalls One Lot of Bupivacaine Hydrochloride

Hospira, Inc., a Pfizer company, is voluntarily recalling one lot of 0.25% bupivacaine hydrochloride injection, USP at the hospital/retail level due to the presence of particulate matter within a single vial. The issue was identified through a confirmed complaint. The drug is indicated for the production of local or regional anesthesiaor analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures.

To date, Hospira has not received reports of any adverse events associated with this issue for this lot. 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. The risk is reduced by the possibility of detection, as the label contains a clear statement directing the physician to visually inspect the product for particulate matter and discoloration prior to administration.

The product is packaged 50 units of 30 mL single-use teartop vials per case, (25 bottles per tray, two trays per case). The lot was distributed nationwide in the US to wholesalers and hospitals between December 2015 and January 2016. Hospira has initiated an investigation to determine the root cause and corrective and preventive actions.

Source: Hospira and US Food and Drug Administration

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