June 18, 2014 — The U.S. Food and Drug Administration (FDA) and Hospira Inc. have announced a voluntary recall for one lot of Marcaine (bupivacaine), an anesthetic, after receiving a customer complaint of visible particles contaminating a vial of the drug.
The customer complained that there were particles embedded in the glass vial and floating in the solution. Hospira traced the problem to a supplier’s glass vials.
- 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.
Hospira has received no adverse event reports, but they outlined several scenarios in which particulate matter could cause a patient injury. If the particles were large, they could block administration of the drug and delay therapy. However, the particles are probably too small to cause this problem.
Large particles could also potentially interact with a strong magnetic field from an MRI, but again, the particles are probably too small and Hospira says this risk is “extremely unlikely.”
The most likely scenario involves local tissue reactions:
“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.”
Hospira recommends that customers should immediately stop using the recalled products and quarantine them from inventory. The company will be contacting distributors and customers via letter with further instructions on how to return the products.
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