Hospira Lidocaine Nationwide Recall


Recall Number: #efa649e144
Date Published: July 28, 2014
Manufacturer: Hospira, Inc

Hazards

Delay in Therapy, Inflammation, Tissue Damage

Summary by USRecalls.org

Hospira, Inc. has issued a voluntary Nationwide recall Of one lot of Lidocaine HCI Injection, USP, 2 percent, 20 mg per mL Single-dose Vial, Preservative-free due to the detection of particulate matter. The particle detected has been identified as iron oxide. If the Lidocaine is administered without the particle being detected it can cause a delay in therapy, it may pass through the catheter and cause local inflammation and mechanical disruption of tissue or immune response to the particulate. If exposed to MRI can dislodge and cause tissue damage.

FDA Official Description

Hospira, Inc. (NYSE: HSP), announced today it will initiate a voluntary recall of one lot of Lidocaine HCI Injection, USP, 2 percent, 20 mg per mL, 5 mL single-Dose Vial, Preservative-Free (NDC 0409-2066-05; Lot 25-550-DD, Expiry 1JAN2015) to the user level due to a confirmed customer report of discolored product with visible particles in the solution as well as particulate embedded in the molded glass container. Hospira has identified the particulate as iron oxide. To date, Hospira has not received reports of any adverse events associated with this issue for this lot.

Products Affected

Lidocaine HCI Injection, USP, 2%, 20 mg per mL, 5 mL single-Dose Vial, Preservative-Free (NDC 0409-2066-05; Lot 25-550-DD, Expiry 1JAN2015)

What do I do next?

Anyone with who has the recalled lot of Lidocaine should immediately stop use. Hospira will be notifying its direct distributors/customers via a letter and will make arrangements for effected product to be returned to be returned. For additional assistance, call Stericycle at1-855-827-6586 (M-F, 8 a.m. - 5 p.m. ET).