Hospira, Inc. is voluntarily recalling one lot of the local anesthetic Bupivacaine Hydrochloride because particulate matter was found in a vial of the drug.
The recalled medication is one lot of 0.25% Bupivacaine Hydrochloride Injection, USP (NDC: 0409-1159-02, Lot 59-064- DK, Expiry 1NOV2017. The issue was identified through a confirmed complaint, the Food and Drug Administration (FDA) said.
If particulate matter is administered to a patient, it may result in “local swelling, irritation of blood vessels or tissue, blockage of blood vessels and/or low-level allergic response to the particulate,” according to the FDA. There is a statement on the label directing the physician to visually inspect the vial for particulate matter and discoloration before administering the drug.
According to the recall announcement, Hospira has not received reports of any adverse events associated with the problem for this lot. The recalled Bupivacaine is used for local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures.
The product is packaged 50 units of 30 mL Single-use Teartop Vials per case (25 bottles per tray, two trays per case). The now-recalled lot was distributed nationwide in the U.S. to wholesalers and hospitals between December 2015 and January 2016. Hospira has begun an investigation to determine the cause and to take corrective and preventive actions.
Any facility with an inventory of the recalled lot of Bupivacaine should stop use and distribution of the medication and quarantine the product immediately, the FDA advises. Facilities should inform health care professionals in the organization of this recall. If a facility has further distributed the recalled product, they should notify any account or location to which they have distributed the product. Hospira will notify direct customers by a recall letter and is arranging for impacted product to be returned to Stericycle in the United States. For assistance, customers may call Stericycle at 1-888-570-1678 between the hours of 8 a.m. to 5 p.m. ET, Monday through Friday.
The FDA encourages doctors or patients to report adverse reactions or quality problems to the FDA’s MedWatch Adverse Event Reporting program online, by regular mail, or by fax.