Hospira announced a voluntary recall of one lot of Lidocaine HCl Injection, 2% due to a confirmed customer report of discolored product with visible particles. Particles were detected in the solution and embedded in the molded glass container. The affected product is supplied as a 20mg/mL strength in 5mL single-dose vials and are preservative-free. The affected products have NDC # is 0409-2066-05, Lot # 25-550-DD, and an expiration date of January 1, 2015.
The particulate has been identified as iron oxide. Some related risk factors include the possibility of the particulate being injected and/or a delay in therapy. Hospira stated that it is unlikely for the particulates to block administration of the drug to the patient. If particulates pass through the catheter, it may result in local inflammation, mechanical tissue disruption, or immune response to the particulate.
Hospira will be notifying its distributors/customers via a recall letter and will arrange for the affected product to be returned. Hospira is working with its supplier to implement corrective and preventive actions.
For more information call (800) 441-4100 or visit Hospira.com.