Hospira is voluntarily recalling one lot of its 0.25% bupivacaine hydrochloride injection at the hospital and retail level.
Hospira is voluntarily recalling one lot of its 0.25% bupivacaine hydrochloride injection at the hospital and retail level because of potential particulate matter contamination in a single vial.
The product is packaged as 50 units of 30-mL, single-use, tear-top vials per case. The recalled lot (59-064- DK) was distributed to US wholesalers and hospitals between December 2015 and January 2016, and its products are marked with an expiration date of November 1, 2017.
In the event that a contaminated product is administered to a patient, he or she may experience local swelling, blood vessels irritation or blockage, or low-level allergic response.
To date, Hospira has not received any notice of adverse events related to the recalled lot. The risk of patient complications can be reduced by visibly detecting the particulate matter before the bupivacaine hydrochloride is administered. The products have instructions on their labels that direct health care professionals to visually inspect them before use.
Hospira is currently investigating how the contamination occurred in order to take preventative actions. In the meantime, those who have the recalled products are advised to stop use and quarantine them immediately. Distributors are being instructed to notify clients who may have received the recalled product, as well.