Recall Alert: FDA Updates its Nationwide Alert on Counterfeit One Touch Blood Glucose Test Strips; Constitutes a Class I Recall

December 2006: 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.

Source: FDA