Hospira announced a voluntary nationwide recall of one lot of Marcaine (bupivacaine HCl) injection, 0.25%, 75mg/30mL, after a confirmed report of discolored solution with visible particles inside the glass vial as well as embedded in the glass.
The particulate, identified as iron oxide measuring 3mm in diameter, has been attributed to a supplier’s glass defect.
Marcaine is a local anesthetic 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 (0.25% and 0.5% only).
If the particulate goes undetected and the solution is administered, the particle may potentially block the infusion of the solution to the patient. Iron particulates may put a patient at risk from MRI because it could potentially dislodge and be pulled through tissue causing inflammation and tissue trauma.
The administration of an injectable with the presence of foreign particulates may potentially cause thrombophlebitis, bacteremia, sepsis, endocarditis, and death may result.
The affected product has Lot # 25-220-DD and NDC 0409-1559-30. Marcaine is packaged in 10 units per carton/100 units per case in glass fliptop vials and were distributed August 2013–October 2013.
For more information call (866) 891-1984 or visit the FDA Safety Alert page.