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FDA NEWS RELEASE

FOR IMMEDIATE RELEASE
P06-174
October 23, 2006

Media Inquiries:
Megan Moynahan, 301-827-6242
Consumer Inquiries:
888-INFO-FDA


 

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.

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