Hospira is initiating a voluntary nationwide recall for one lot of Lidocaine HCl Injection 2%, 5mL single-dose vials due to a reddish orange particulate on the inner surface and floating in the solution.
Lidocaine HCl is indicated for local or regional anesthesia for infiltration and nerve block.
The affected vials have Lot # 32-135-DD and NDC #0409-2066-05 with an expiration of 1AUG2015. The product was distributed between September through October 2013 in 10 units/carton and 180 units/case in single-dose glass fliptop vials.
If the particulate is undetected in solution and gets administered, it may potentially block the infusion of the solution to the patient, resulting in a delay of therapy.
Smaller pieces of the particulate may pass through the catheter into the patient, resulting in local inflammation or mechanical disruption of tissue. In addition, local granuloma formulation is possible following sequestration.
If there is iron within the infused particle, it may put a patient at risk when undergoing MRI, as the particle could potentially be dislodged and be pulled through tissue and cause local inflammation and tissue trauma.
Hospira 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 (855) 695-8596 or visit the FDA MedWatch page.