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FDA Recall Alert: Hospira Announces Voluntary Recall of One Lot of 1 Percent Lidocaine HCI Injection, USP, Due to Visible Particulates

From ASCRS/ASOA Bulletin:

On Friday, April 18, 2014, the Food and Drug Administration (FDA) alerted providers that Hospira, Inc. is conducting a nationwide recall of one lot of 1% Lidocaine HCI Injection, USP, 10mg/mL, 30mL single dose, preservative-free to the user level due to a confirmed customer report of orange and black particulate within the solution and embedded within the glass vial.

Hospira has identified the particulate as iron oxide.  Risk factors associated with the particulate include the potential for particulate to be injected and a delay in therapy.

This lot, Lot # 31-427-DK, was distributed nationwide to distributors, wholesalers, hospitals and clinics from September 2013 through October 2013. The lot expires on July 1, 2015.

Customers are advised to check inventory and immediately stop use and quarantine any affected product.  In addition, customers should inform potential users of this product in their organizations of this notification.

Hospira will be notifying its direct distributors/customers via a recall letter and will arrange for impacted product to be returned to Stericycle, which can be contacted at 1-888-835-2723.  For medical inquiries, contact Hospira Medical Communications at 1-800-615-0187.  

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by mail or by fax.

• Complete      and submit the report online: www.fda.gov/medwatch/report.htm
• Mail      or fax: download form www.fda.gov/MedWatch/getforms.htm      or call 1-800-332-1088 to request a reporting form, then complete and      return to the address on the pre-addressed form, or submit by fax to      1-800-FDA-0178.

If you need additional information, please contact Ashley McGlone, manager of regulatory affairs, at amcglone@ascrs.org or 703-591-2220.