2% Lidocaine HCL Injection by Hospira: Recall - Presence of Particulate Matter
Tuesday, December 24, 2013
ISSUE: Hospira, Inc. announced it will initiate a voluntary
nationwide recall to the user level for one lot of Lidocaine HCl Injection,
USP, 2%, 5 mL Single-Dose Vial (NDC 0409-2066-05), Lot 32-135-DD, expiration
date 1AUG2015. The recall is due to a reddish orange particulate on the inner
surface and floating in the solution.
If 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. If
smaller pieces of the particulate break off and become free floating within the
solution, they may pass through the catheter into the patient, resulting in
local inflammation or mechanical disruption of tissue. Chronically, following
sequestration, local granuloma formulation is possible. In consideration of the
reddish orange color of the particulate, if there is iron within the particle
that is infused, it may put a patient at risk when undergoing MRI (strong
magnetic field exposure), as the particle could potentially be dislodged and be
pulled through tissue, causing local inflammation and tissue trauma.
Lidocaine is packaged 10 units
per carton/180 units per case in single dose glass fliptop vials.
The recalled lot was
distributed to distributors/wholesalers, hospitals, and pharmacies located in
AL, AZ, CA, CO, FL, GA, HI, IL, IN, KY, LA, MD, MA, MI, MS, MO, NV, NJ, NC, OH,
OK, PA, TN, TX, UT, VA, WA, and WI between September 2013 through October 2013.
Hospira became aware of the issue after receiving a complaint of particles in
the glass vial. To date, Hospira has not received reports of any adverse events
associated with this issue for this lot. Hospira believes the embedded
particulate is related to a supplier’s glass defect.
RECOMMENDATION: Anyone with an existing inventory should immediately stop
use and quarantine any affected product and return the product to Stericycle.
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 1-855-695-8596
between 8 a.m. and 5 p.m., ET, Monday through Friday.
For clinical inquiries,
please contact Hospira using the information provided below.
Hospira Global Complaint
CT, M-F) (ProductComplaintsPP@hospira.com)
To report adverse events
or product complaints
email@example.com (Available 24 hours a day/7 days per week)
Healthcare professionals and patients are encouraged to
report adverse events or side effects related to the use of these products to
the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form,
then complete and return to the address on the pre-addressed form, or
submit by fax to 1-800-FDA-0178
Source: U.S. Food and Drug
Administration (FDA) (Accessed: 12/24/2013)