ISSUE: Hospira announced a voluntary nationwide recall to the user level for one lot of 0.5% Marcaine (Bupivacaine HCl Injection, USP), 30 mL, Single-dose Vial – Preservative Free (NDC 0409-1560-29), Lot 33-545-DD. The recall is due to a confirmed customer report of particulate embedded in the glass vial as well as visible particulate in the solution. Hospira has attributed the embedded particulate to a supplier’s glass defect. Hospira is working with its supplier on implementing corrective and preventive actions.
Administered solution with particulate - depending on the particle size and number - could block administration of the drug to the patient, causing a delay in therapy. Particulate exposed to strong magnetic fields (e.g. MRI), could potentially dislodge and cause tissue damage.
BACKGROUND: Marcaine is packaged 10 units per carton/100 units per case in glass fliptop vials. The impacted lot of Marcaine was distributed November 2013 through March 2014 to wholesalers/distributors, hospitals and clinics nationwide.
RECOMMENDATION: Anyone with an existing inventory should immediately stop use and quarantine any affected product. In addition, customers should inform potential users of this product in their organizations of this notification. Hospira will be notifying its direct distributors/customers via a recall letter and will arrange for impacted product to be returned to Stericycle for returns processing. For additional assistance, call Stericycle at 1-888-656-6380 (M-F, 8 a.m. - 5 p.m. ET).
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Read the MedWatch safety alert, including a link to the Press Release here.
Source: U.S. Food and Drug Administration (FDA) (Accessed: 6/18/2014)