FDA Updates its Nationwide Alert on Counterfeit Blood Glucose Test Strips
On October 13, 2006, the U.S. Food and Drug
Administration (FDA) alerted the public to
counterfeit blood glucose test strips being sold in
the United States 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
announcement provides two additional lot numbers
that are included in the distribution of counterfeit
products, along with descriptions of how to identify
them.
The counterfeit test strips are:
* One Touch Basic®/Profile® (lot #272894A,
2619932, 2606340, and 2615211 (new)) test strips; and,
* One Touch Ultra® (lot #2691191 and 2691261
(new)) test strips.
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.
LifeScan alerted FDA of the 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
* The lot number 272894A, 2619932, or 2606340
appears on the outer carton and on the inner
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 number 2615211
* The lot number 2615211 appears on the outer
carton and on the inner 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 inner container is labeled as
“plasma-calibrated”.
Counterfeit One Touch Ultra Test Strips, lot
numbers 2691191 and 2691261
* The lot number 2691191 or 2691261 appears on
the outer carton and on the inner container (vial).
* The outer carton and the inside container
(vial) are 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, LifeScan alerted the public
via a press release and notified pharmacists,
distributors, and wholesalers through a letter. In
its letter, the company advised customers to contact
their original source of supply for restitution. For
more information, visit: www.Lifescan.com.
On October 13, 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 through the MedWatch Web site 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.