Advocacy & Practice Updates — Advocacy & Practice

FDA Alert: Hospira Recalls Marcaine (Bupivacaine HCI Injection, USP)

Particulate matter found in solution, glass vial

The US Food and Drug Administration (FDA) has alerted health care professionals that  Hospira, Inc (Lake Forest, IL) has announced a voluntary nationwide recall to the user level for 1 lot of 0.5% Marcaine (bupivacaine HCl injection, USP), 30 mL, single-dose vial – preservative free (NDC 0409-1560-29), lot 33-545-DD.

The recall is due to a confirmed customer report of particulate embedded in the glass vial as well as visible particulate in the solution. Hospira has attributed the embedded particulate to a supplier’s glass defect, and is working with its supplier on implementing corrective and preventive actions.

According to Hospira, the recalled lot of Marcaine was distributed November 2013 through March 2014 to wholesalers/distributors, hospitals, and clinics across the United States.

If you have any inventory of the recalled product, you are advised to immediately stop use and quarantine it. Please also inform potential users of this product in your organization of this notification.

Hospira will notify its direct distributors/customers via a recall letter and will arrange for the recalled product to be returned to Stericycle for returns processing. For more information, call Stericycle at 1-888-656-6380 Monday through Friday between 8:00 AM and 5:00 PM Eastern Time.

For more details, see the Hospira news release.

To report an adverse event or side effect:

  • Download the form or call 800-332-1088 to request the reporting form. Complete and return it to the address on the form, or fax to 800-FDA-0178. 

Published June 2014