Hospira announced a voluntary recall of 1 lot of 0.25% Bupivacaine HCl Injection, USP, due to the presence of particulate matter within a single vial reported through a confirmed complaint. Hospira is investigating the root cause and determining corrective and preventive actions.
Bupivacaine HCl Injection is indicated for local or regional anesthesia or analgesia for surgery, dental, and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures.
If a product containing particulate matter is administered to a patient, it may lead to local swelling, irritation of blood vessel or tissue, blockage of blood vessels and/or low-level allergic response to the particulate. To date, there have not been reports of any adverse events associated with this issue for the recalled lot.
The affected product has Lot #59-06-DK with an expiration date of November 1, 2017. It is supplied as 50 units of 30mL single-use teartop vials per case (25 bottles per tray, 2 trays per case). The lot was distributed nationwide between December 2015 and January 2016. Those with an existing inventory of the recalled lot should discontinue use and quarantine the product immediately.
For more information call (888) 345-4680 or visit FDA.gov.