FDA Updates its Nationwide Alert on Counterfeit Blood Glucose Test Strips
Actions Constitute a Class I Recall
The U.S. Food and Drug Administration (FDA) is
providing an update to its notifications on October
13, and October 23, 2006, alerting the public to
counterfeit blood glucose test strips being sold in
the US for use with various models of LifeScan,
Inc., One Touch Brand Blood Glucose Monitors. These
test strips are used by people with diabetes to
measure their blood glucose. Today’s update includes
an additional lot number that is being distributed,
along with a description of how to identify the new lot.
FDA has classified the current situation as a
Class I recall because some of the counterfeit
products have significant deviations in performance.
The counterfeit test strips potentially could give
incorrect blood glucose values-- either too high or
too low--which might result in a patient taking
either too much or too little insulin and lead to
serious injury or death.
The products of concern are counterfeit – they
are not marketed or distributed by Lifescan, and
Lifescan is not responsible for conducting the
recall. Rather, firms that are distributing the
counterfeit product are responsible for conducting
the recall using corrective actions developed by
Lifescan, with input from FDA. FDA continues to work
with Lifescan and the distributors to ensure that
counterfeit products are removed from the market.
The counterfeit test strips are:
- One Touch® Basic®/Profile® (lot #272894A,
2619932, 2606340, 2615211 (added October 23, 2006)
and 227078A (new lot)) test strips, and
- One Touch® Ultra® (lot #2691191 and 2691261
(added October 23, 2006) test strips.
LifeScan, Inc. alerted FDA of the new lot of
counterfeit test strips. The FDA continues to
investigate the matter, including whether there have
been any adverse events associated with this
counterfeit product.
Consumers who have the counterfeit test strips
should stop using them, replace them immediately and
contact their physician. Consumers with questions
may contact LifeScan, Inc. at 1-866-621-4855.
Consumers who have discarded the outer box or do not
know the lot number of their test strips should stop
using those test strips and replace them.
The counterfeit test strips were distributed to
pharmacies and stores nationwide by various
distributors.
How to Identify
For complete information on how to identify the
counterfeit test strips, please check LifeScan’s web
site at
www.lifescan.com/company/about/press/counterfeit/.
The following characteristics may help to
identify the counterfeit test strips:
Counterfeit One Touch Basic/Profile Test Strips,
lot numbers 272894A, 2619932, and 2606340
- Lot Numbers 272894A, 2619932, or 2606340
appears on the outer carton and on the inside
container (vial).
- The outer carton is written in Multiple
Languages including English, Greek and Portuguese.
- The outer carton is labeled as 50-Count One
Touch (Basic/Profile)Test Strip packages
- The bottom of the outer carton does not include
an NDC number.
Counterfeit One Touch Basic/Profile Test Strips, lot
numbers 2615211 and (227078A (new lot))
- Lot Numbers 2615211 or 227078A appear on the
outer carton and on the inside container (vial).
- The outer carton is written in English.
- The outer carton is labeled as 50-Count One
Touch (Basic/Profile) Test Strip packages.
- A picture of a hand appears on the test strip
displayed on the outer carton.
- The inside container (vial) is labeled as
“plasma calibrated”
- The bottom of the outer carton does not include
an NDC number.
Counterfeit One Touch Ultra Test Strips, lot
numbers 2691191 and 2691261
- The lot numbers 2691191 or 2691261 appears
on the outer carton and on the inside container (vial).
- The outer carton and inside container (vial) is
written in both English and French.
- The outer carton is labeled as 50-Count One
Touch Ultra Test Strip packages.
- The bottom of the outer carton does not include
an NDC number.
On October 13, 2006 (later updated October 26,
2006), LifeScan alerted the public via a press
release and notified pharmacists, distributors, and
wholesalers through a letter. The firm advised
customers to contact their original source of supply
for restitution. For more information, visit www.Lifescan.org .
On October 13, 2006 (later updated October 23,
2006), FDA alerted its Counterfeit Alert Network
partners, a coalition of healthcare professional,
consumer and trade associations, who have agreed to
further disseminate this important information in a
timely and effective manner. For more information
about this and other counterfeit products, visit
www.fda.gov/counterfeit/.
Any adverse reactions experienced with the use of
this product, and/or quality problems should also be
reported to the FDA’s MedWatch Program by phone at
1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at
MedWatch, HF-2, FDA, 5600 Fishers Lane, Rockville,
MD 20852-9787, or on the MedWatch website at
www.fda.gov/medwatch.
About The SafeMeds Alert System
The SafeMeds Alert System is a counterfeit alert
distribution service of the the Partnership for Safe
Medicines--a group of
organizations and individuals that have policies,
procedures, or programs to protect consumers from
counterfeit or contraband medicines.