The propofol recall comes due to a glass defect located on the interior neck of the vial, which was related to a manufacturing process for the Illinois-based company.
The defect was identified during a sample inspection where the glass vial contained visible embedded metal particulate. Free-floating metal particulates were also identified in vials upon further analysis.
Hospira spokesman Dan Rosenberg told in- “Regarding the propofol recall, Hospira has implemented corrective actions to the manufacturing process to prevent recurrence.
The voluntary recall of one lot of 1% Lidocaine HCI Injection, USP, 10mg/mL, 30 mL single dose, Preservative - Free to the user level came after a confirmed customer report of orange and black particulate within the solution and embedded within the glass vial.
Hospira 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.
“Regarding Lidocaine, Hospira has attributed the embedded particulate to a supplier’s glass defect,” Rosenberg added.
“As a result of this issue, Hospira is working with its supplier on implementing corrective and preventive actions. To date, Hospira has not received reports of any adverse events associated with either of these product issues.”
The recalls come as Hospira is looking to put its finishing touches on fixes at its Rocky Mount, North Carolina plant. That facility was recently upgraded by the US FDA to VAI (voluntary action indicated) status , though a warning letter from 2010 still stands. Both the North Carolina and another injectables plant in Texas are slated to return to full production.
The good news comes as Hospira also agreed to settle a lawsuit for $60m after being accused of manufacturing and quality control deficiencies at the Rocky Mount plant.