Lidocaine HCI Injection, USP, 2 percent, by Hospira: Recall - Visible Particulates

[Posted 07/30/2014]

AUDIENCE: Pharmacy, Patient, Health Professional, Nursing

ISSUE: Hospira, Inc. is recalling one lot of 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) 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.

Risk factors associated with the particulate include the potential for particulate to be injected and/or a delay in therapy. If the particulate goes undetected and solution is administered - depending on the particle size and number - it could block administration of the drug to the patient, causing a delay in therapy. Particulates may be able to pass through the catheter and may result in local inflammation, mechanical disruption of tissue or immune response to the particulate. While extremely rare, particulate exposed to strong magnetic fields (e.g. MRI), could potentially dislodge and cause tissue damage.

BACKGROUND: Lidocaine is packaged 10 units per carton / 180 units per case in single-dose glass fliptop vials. This lot was distributed nationwide to distributors/wholesalers, hospitals and clinics from June 2013 through July 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 is notifying its direct distributors/customers via a recall letter and will arrange for impacted product to be returned to Stericycle for return processing. For additional assistance, call Stericycle at1-855-827-6586 (M-F, 8 a.m. - 5 p.m. ET). For clinical inquiries, refer to the Firm Press Release.

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

[07/29/2014 - Firm Press Release - Hospira, Inc]