June 18, 2014 — Hospira Inc. has announced a recall for one lot of Marcaine (bupivacaine), a local anesthetic drug, because it may be contaminated with particulate matter.
The recall was initiated after Hospira confirmed a customer report of particulate embedded in the glass vial as well as visible particulate in the solution. The problem has been attributed to a supplier’s defective glass vial.
No adverse events have been reported and Hospira believes the problem is unlikely to cause a serious injury. Large particulate could block administration of the drug and delay therapy, but the particles are probably too small to cause this complication.
It is also possible that particulate exposed to a strong magnetic field could cause tissue damage, but again, the particles are very small and this adverse event is “extremely unlikely.”
According to Hospira:
“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.”
- 0.5% Marcaine™ (Bupivacaine HCl Injection, USP), 30 mL, single-dose vial – Preservative Free (NDC 0409-1560-29), Lot 33-545-DD. Products were sold between November 2013 and March 2014 to wholesalers, hospitals, and clinics nationwide.
The U.S. Food and Drug Administration (FDA) recommends that anyone who has these products should quarantine them from inventory and immediately stop using them. Hospira will also be notifying distributors and customers via a recall letter that will provide instructions on how to arrange a return.
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