Advocacy & Practice Updates — Advocacy & Practice

FDA Alert: Hospira Recalls Lidocaine HCI Injection, USP, 2%

Visible particles found in solution and embedded in molded glass container

The US Food and Drug Administration (FDA) has announced that Hospira, Inc. (Lake Forest, IL) is recalling one lot of Lidocaine HCI Injection, USP, 2%, 20 mg per mL, 5 mL single-dose vial, preservative-free (NDC 0409-2066-05; Lot 25-550-DD, Expiry 1JAN2015) to the user level.

According to the FDA, the recall is due to a confirmed customer report of discolored product with visible particles in the solution as well as particulate embedded in the molded glass container. Hospira, says the FDA, has identified the particulate as iron oxide.

Lidocaine is packaged 10 units per carton/180 units per case in single-dose glass fliptop vials. The recalled lot was distributed nationwide to distributors/wholesalers, hospitals, and clinics from June 2013 through July 2013.  

The FDA states that if you have any inventory of the recalled product, you should immediately stop its use and quarantine it. You are also advised to inform potential users of this product in your organization of this notification.

According to the FDA, Hospira is notifying its direct distributors and customers via a recall letter and will arrange for the recalled product to be returned to Stericycle for return processing. For additional assistance, call Stericycle at 1-855-827-6586 Monday through Friday, 8:00 AM to 5:00 PM Eastern Time.

For clinical inquiries, 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. 

 Updated July 30, 2014

Designed and built in Chicago by Webitects