Hospira is recalling one lot of an injectable anesthetic due to contamination with particulate matter, which was identified in a single vial. The voluntary recall affects one lot of 0.25% Bupivacaine Hydrochloride Injection, USP (NDC: 0409-1159-02, Lot 59-064- DK, Expiry 1NOV2017). Hospira, a Pfizer company, learned of the contamination through a confirmed complaint.
According to a recall notification posted on the U.S. Food and Drug Administration’s (FDA’s) website, 0.25% Bupivacaine Hydrochloride Injection, USP is used for local or regional anesthesia. It is used for surgery, dental and oral procedures, diagnostic and therapeutic procedures and for obstetric procedures. If the contaminated product is injected into a patient, it may cause local swelling, irritation of blood vessels or tissue, blockage of blood vessels and/or low-level allergic response. So far, there have been no reports of adverse events related to the contamination.
Hospira says that the risk of harm is lessened by the fact that physicians are instructed to visually inspect the vial for particulate matter and discoloration. As such, the company says, the particulate may be detected visually before it is injected into a patient.
The recalled lot was distributed to wholesalers and hospitals nationwide between December 2015 and January 2016. The injections come in 30 mL Single-use Teartop Vials; there are 25 bottles per tray and two trays for case, totaling 50 units altogether. In its press release, Hospira says it is investigating the cause of the contamination.
Anyone in possession of the recalled products are urged to stop using and distributing them immediately. Healthcare professionals in the affected organization should be informed of the issue.