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.
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.
http://www.fda.gov/Safety/Recalls/ucm379739.htm
For clinical inquiries, please contact Hospira using the information provided below.
| Hospira Contact | Contact Information | Areas of Support |
|---|---|---|
| Hospira Global Complaint Management | 1-800-441-4100 (8am-5pm CT, M-F) (ProductComplaintsPP@hospira.com) | To report adverse events or product complaints |
| Hospira Medical Communications | 1-800-615-0187 or medcom@hospira.com (Available 24 hours a day/7 days per week) | Medical inquiries |
