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RODERICK L. BREMBY, SECRETARY |
K A N S
A S
DEPARTMENT
OF HEALTH AND ENVIRONMENT |
KATHLEEN SEBELIUS, GOVERNOR |
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For Immediate Release
October 24, 2006 |
Mike Heideman, KDHE
(785) 296-4363
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UPDATE: KDHE and FDA Alert on Counterfeit One Touch Basic/Profile
and One Touch Ultra Blood Glucose Test Strips
The Kansas Department of Health and Environment (KDHE) and the U.S. Food and Drug Administration (FDA) are updating an earlier warning about 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 used by people with diabetes to measure their blood glucose.
Two additional lot numbers are now included among the counterfeit products. They are:
- One Touch Basic®/Profile® test stripslot # 2615211 (lot #272894A, 2619932, 2606340 were previously determined to be counterfeit).
- One Touch Ultra® test strips lot #2691261 (lot #2691191 was previously determined to be counterfeit).
The counterfeit test strips were distributed to pharmacies and stores nationwide by various distributors. The counterfeit test strips potentially could give incorrect blood glucose values – either too high or too low – which might result in a patient taking too much or too little insulin, possibly leading to serious injury or death.
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 appear 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 2651211 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.
The FDA continues to investigate the matter, including whether there have been any adverse events associated with these counterfeit products. 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. 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/.
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