Hospira Issues a Voluntary Nationwide Recall of One Lot of 0.25% Marcaine™ (Bupivacaine HCL Injectio
Monday, October 21, 2013
Hospira Issues a Voluntary Nationwide Recall of One Lot of 0.25% Marcaine™ (Bupivacaine HCL Injection, USP), 75mg/30ml, Single-Dose - Preservative Free Vial Due to Presence of Particulate Matter
ISSUE: Hospira, Inc. announced it will initiate a
voluntary nationwide recall to the user level for one lot of 0.25% Marcaine™
(Bupivacaine HCl Injection, USP), 75 mg/30 mL, Single-dose Vial – Preservative
Free (NDC 0409-1559-30), Lot 25-220-DD. The recall is due to a confirmed
customer report of discolored solution with visible particles inside the glass
vial as well as embedded in the glass. The embedded particulate was identified
as iron oxide measuring approximately 3mm in diameter. To date, Hospira has not
received reports of any adverse events associated with this issue for this lot.
Hospira has attributed the embedded particulate to a supplier's glass defect.
As a result of this issue we are working with our supplier on implementing
corrective and preventive actions.
If the particulate goes
undetected and solution is administered, the particle may potentially block the
infusion of the solution to the patient, resulting in a delay in therapy. Iron
particulate may put a patient at risk from MRI (strong magnetic field exposure)
as metal particulate, 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, and/or endocarditis and death may result.
Signs and symptoms could include redness, pain, swelling at the site, fever,
shortness of breath, tachycardia, nausea, and vomiting.
Marcaine is packaged 10
units per carton/100 units per case in glass fliptop vials. The impacted lot of
Marcaine was distributed August 2013 through October 2013 to
wholesalers/distributors, hospitals and pharmacies.
with an existing inventory should immediately stop use and quarantine any
affected product and return the product to Stericycle.
For contact information regarding the return
of products or clinical inquiries please see the Firm Press Release at http://www.fda.gov/safety/recalls/ucm371412.htm.
Source: U.S. Food and Drug
Administration (FDA) (Accessed: 10/21/2013)