Hospira announced a voluntary recall of one lot of 0.5% Marcaine (Bupivacaine HCl), injection, USP, 30mL, single-dose, preservative-free vials due to visible particles embedded in the glass, as well as visible particulate in the solution after a customer complaint. Upon investigation, Hospira determined that the embedded particle was due to the supplier’s glass defect.
Bupivacaine HCl injection is indicated for the production of 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 Lot 33-545-DD and was distributed nationwide from November 2013 to March 2014 to wholesalers/distributors, hospitals, and clinics nationwide. 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 and result in local inflammation or mechanical disruption of tissue. Although the occurrence is rare, 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 return/replacement of all recalled product.
For more information call (800) 386-2076 or visit FDA.gov.