Lidocaine HCI Injection, USP, by Hospira: Recall - Visible Particulates
Saturday, April 19, 2014
ISSUE: Hospira, Inc. will initiate a voluntary recall of one lot of 1% Lidocaine HCI Injection, USP, 10mg/mL, 30 mL 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/or a delay in therapy.
If the particulate or smaller pieces of the particulate that could break off, become free floating within the solution pass through the catheter into the patient, it may result in local inflammation, and/or mechanical disruption of tissue or immune response to the particulate. Chronically, following sequestration, local granuloma formulation may occur.
BACKGROUND: This lot (Lot # 31-427-DK, Expiration Date 1JUL2015) was distributed nationwide to distributors/wholesalers, hospitals and clinics from September 2013 through October 2013.
RECOMMENDATION: Anyone with existing inventory should 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 for returns processing. For additional assistance, call Stericycle at 1-888-835-2723. For medical inquiries, please contact Hospira Medical Communications at 1-800-615-0187.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form 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
Read the MedWatch safety alert, including a link to the Press Release HERE.
Source: U.S. Food and Drug Administration (FDA) (Accessed: 4/19/2014)