Patient Safety News
Blog Home All Blogs
Search all posts for:   


View all (99) posts »

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

Posted By Administration, Monday, October 21, 2013

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.

RECOMMENDATION: Anyone 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

Source: U.S. Food and Drug Administration (FDA) (Accessed: 10/21/2013)

Tags:  FDA  Patient Safety  Recall 

Share |
Permalink | Comments (0)

Contact Us

120 E. Ogden Ave. Ste. 202
Hinsdale, Illinois 60521
P: 630.203.2252
Toll Free: 888.255.0005

© Copyright 2016 Spine Intervention Society Privacy Policy  ::  Legal