Hospira, Inc., announced a voluntary recall of one lot of single-dose vials of Lidocaine HCI Injection, due to a customer complaint of discolored product with visible particles, identified as iron oxide, in the solution. Particulate also was embedded in the molded glass container, according to the recall announcement from Hospira.
The company has attributed the embedded particulate to supplier’s glass defect and is working with its supplier on implementing corrective and preventive actions.
The recall, which is to the user level, is for 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). The product was packaged 10 units per carton/180 units per case in single-dose glass fliptop vials and was distributed nationwide to distributors/wholesalers, hospitals, and clinics from June 2013 through July 2013.
Risk factors associated with the particulate include the potential for particulate to be injected and/or a delay in therapy. Hospira reports that it has not received reports of any adverse events associated with this issue for this lot.
Source: FDA and Hospira