Hospira announced a voluntary nationwide recall of one lot of 0.25% Marcaine (bupivacaine HCl) injection, single-dose 10mL vials due to discolored solution with visible particles embedded in the glass as well as the presence of discolored solution. Upon investigation, Hospira determined that the embedded particle was due to the supplier’s glass defect.
Marcaine is a local anesthetic indicated for local or regional anesthesia or analgesia for surgery, dental, and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures.
The affected vials are from Lot 34-440-DD (NDC 0409-1559-10) and was distributed nationwide between December 2013 and January 2014.
If the particulate is undetected in solution and is administered, it may potentially block the administration of the solution to the patient, resulting in a delay of therapy. Smaller pieces of the particulate may pass through the catheter into the patient, resulting in local inflammation or mechanical disruption of tissue. Although the occurrence is rare, but if the particulate is exposed to strong magnetic fields (eg, MRI), it could potentially dislodge and cause tissue damage.
Hospira advises consumers to immediately stop using any affected products. It will be notifying its direct distributors/customers via a recall letter and will arrange for affected products to be returned to Stericycle for processing.
For more information call (866) 364-8812 or visit the FDA MedWatch page.