Hospira has initiated a voluntary recall of one lot of Lidocaine HCl injection 1%, 10mg/mL, single-dose 30mL vials due to an orange and black particulate found within the solution and embedded within the glass vial as reported by a customer. Lidocaine is a local anesthetic indicated for local or regional anesthesia for infiltration and nerve block.
The affected vials are from Lot #31-427-DK with an expiration date of July 1, 2015, and were distributed nationwide between September 2013 and October 2013.
Local inflammation, and/or mechanical disruption of tissue or immune response may occur if the particulate or smaller pieces of the particulate become free floating within the solution and pass through the catheter into the patient. Chronically, following sequestration, local granuloma formulation may occur.
Hospira advises consumers to immediately stop using any affected products. It will be notifying its direct distributors/customers via a recall letter and will arrange for affected products to be returned to Stericycle for processing.
For more information call (866) 364-8812 or visit the FDA MedWatch page.