Particulate Matter Triggers Hospira Recall of Injection

If the particulate is administered to a patient, it may result in swelling, irritation, or allergic response

Particulate Matter Triggers Hospira Recall of Injection
Image: NCCC
August 5, 2016

Hospira, a Pfizer company, has issued a recall of one lot of 0.25% Bupivacaine Hydrochloride Injection at the hospital/retail level due to the presence of particulate matter within a single vial.

In the event that the particulate 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. 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 milliliter single-use Teartop vials per case, 25 bottles per tray, two trays per case. It consists of one lot of 0.25% Bupivacaine Hydrochloride Injection, United States Pharmacopeia (USP), (National Drug Code (NDC) 0409-1159-02, Lot 59-064-DK, Expiry 1NOV2017). The lot was distributed nationwide in the U.S. to wholesalers and hospitals between December 2015 and January 2016.

To date, Hospira has not received reports of any adverse events associated with this issue for this lot, although the issue was identified through a confirmed complaint.

Anyone with an existing inventory of the recalled lot should stop use and distribution and quarantine the product immediately. Inform Healthcare Professionals in your organization of this recall. If you have further distributed the recalled product, please notify any accounts or additional locations which may have received the recalled product from you. Further, please instruct entities that may have received the recalled product from you that if they redistributed the product, they should notify their accounts, locations or facilities of the recall to the hospital/retail level. Hospira will be notifying its direct customers via a recall letter and is arranging for impacted product to be returned to Stericycle in the United States.

For more information, consumers should call Stericycle at (888) 570-1678 or Hospira at (888) 345-4680.