Hospira Issues Recall Due to Visible Particulates in Vials
On June 17, Hospira, Inc. announced a voluntary nationwide recall to the user level for one lot of 0.5% Marcaine (Bupivacaine HCl Injection, USP), 30 mL, Single-dose Vial – Preservative Free (NDC 0409-1560-29), Lot 33-545-DD. The recall is due to a confirmed customer report of particulate embedded in the glass vial as well as visible particulate in the solution.
Hospira has attributed the embedded particulate to a supplier’s glass defect and reports that it is working with its supplier on implementing corrective and preventive actions. The company reports that to date, it has not received reports of any adverse events associated with this issue for this lot.
In a press statement announcing the recall, Hospira reports that 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. The company reports that this is an unlikely outcome due to the size of the subvisible particulates identified. It is more likely that particulates are 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. However, the particulate size identified is considered too small. Therefore, an adverse outcome is extremely unlikely, the Hospira statement reports.
Marcaine is packaged 10 units per carton/100 units per case in glass fliptop vials. The impacted lot of Marcaine was distributed November 2013 through March 2014 to wholesalers/distributors, hospitals and clinics nationwide.
This recall is being conducted with the knowledge of the US Food and Drug Administration.