Food and Drug Administration (FDA) and Hospira, Inc, of Lake Forest, IL, have issued a voluntary recall of one lot of 1% Lidocaine HCI Injection, USP, 10 mg/mL, 2 mL Multiple-dose Fliptop Vial, National Drug Code 0409-4276-01, Lot 25-090-DK (the lot number may be followed by 01 or 02). The recalled lot was distributed between March 2013 and June 2013. To date, there have been no adverse events associated with the use of this product; the recall was initiated in response to a confirmed customer report of visible particulate (in the form of dark red/black particles) which was identified as oxidized stainless steel. The presence of oxidized stainless steel particulate may potentially put a patient at risk from a strong magnetic field exposure such as with magnetic resonance imaging. Depending on size, if undetected, particles could block administration of the drug to a patient, causing a delay in therapy. Other complications could include local inflammation and phlebitis. Health care providers should stop use and distribution, quarantine the product, and call Stericycle at 866/364-8812 between the hours of 8 am to 5 pm ET, Monday through Friday, to arrange return of the product. Adverse reactions may be reported to FDA’s MedWatch Adverse Event Reporting Program.
