JUL 30, 2014
The U.S. FDA announced that Hospira, Inc. will voluntarily recall one lot of lidocaine injection due to product discoloration and visible particles as well as particulate embedded in the molded glass container. Hospira has identified the particulate as iron oxide.
The recall covers Lidocaine HCI Injection USP, 2%, 20 mg per mL, 5 mL single-Dose Vial, Preservative-Free, lot 25-550-DD, expiring Jan. 1, 2015. It was distributed nationwide to distributors/wholesalers, hospitals and clinics from June 2013 through July 2013.
To date, Hospira has received no report of adverse events associated with this issue for this lot. Hospira has attributed the embedded particulate to supplier’s glass defect and is working with its supplier on implementing corrective and preventive actions.
The FDA advises those with existing inventory to immediately stop use and quarantine any affected product. In addition, customers should inform potential users of this product in their organization. Hospira will be notifying its direct distributors and customers via a recall letter and will arrange for impacted product to be returned to Stericycle for returns processing. For additional assistance, call Stericycle at 1.855.827.6586 , Monday through Friday between 8 a.m. and 5 p.m., Eastern Time.
Adverse reactions associated with this recalled product may be reported to the FDA's MedWatch Adverse Event Reporting Program:
- Submit the report online
- Download form to mail or fax
- 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