A recall of one lot of Marcaine (bupivacaine) has been initiated by Hospira, after a customer reported seeing particulate embedded in a glass vial and in the solution.
The affected lot (0.5% Marcaine [Bupivacaine HCl Injection, USP], 30 mL, Single-dose Vial — Preservative Free [NDC 0409-1560-29], Lot 33-545-DD) was distributed between November 2013 and March 2014 to wholesalers/distributors, hospitals and clinics nationwide.
If the particulate is administered to a patient, it could block administration and cause a delay in therapy. However, the identified particulate is so small, it's more likely to pass through the catheter and cause inflammation, mechanical disruption of tissue or immune response, says the company. There's also an extremely unlikely possibility that if exposed to a strong magnetic field, such as an MRI, the particulate could dislodge and cause tissue damage.
Hospira says it hasn't received any reports of adverse effects associated with the lot, and that the problem is the result of a supplier's glass defect.
The affected product should immediately be pulled and quarantined, says Hospira, which is issuing recall letters to customers and distributors and arranging for it to be returned to Stericycle, which can be reached at 1-888-656-6380.