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SafetyAlerts
January 22, 2001

ADCON® Recalled Worldwide

Cleveland, OH (SafetyAlerts) - Gliatech Inc. announced today that it is implementing a voluntary recall of ADCON(R)-L worldwide and ADCON(R)-T/N outside of the U.S. as a result of a voluntary recall by the supplier of a raw material used in the production of ADCON(R) gel. As previously announced, Gliatech voluntarily discontinued distribution of ADCON(R)-L worldwide and ADCON(R)-T/N outside of the U.S. (collectively "ADCON(R) gel") on January 8, 2001.

As previously announced, Gliatech has implemented quality procedures including pre-production inspection of this raw material and testing of samples of ADCON(R) gel, and Gliatech remains confident that its products are safe and effective. Gliatech has elected to take the additional step of voluntarily recalling its products until the manufacturing process with new supplies of the raw material in a modified container can be tested, validated and approved by the U.S. Food and Drug Administration ("FDA") and European regulatory authorities.


The raw material was recalled by the supplier due to potential particulates in the raw material from the aluminized paper lid liner. Gliatech has received new supplies of the raw material from the supplier in a modified container suitable for production of ADCON(R) gel. Gliatech and the
supplier have begun the design and validation testing procedures which will be used for the Company's submission to the FDA to initiate production of ADCON(R) gel with the new raw material. Gliatech anticipates initiating production and reintroducing ADCON(R) gel to the marketplace as soon as Gliatech receives approval from the FDA and European regulatory authorities.

The application for review of the change in the manufacturing process will be made and reviewed by the FDA in accordance with the Application Integrity Policy regulations, and the timing of such review is uncertain.

 
Selected Recent Recalls


Health Professional:

Did you know?
During 2000 there were over
1050 products recalled in the United
States for safety reasons!

How many did you hear about?

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The information contained herein has been obtained from sources that the Company believes to be reliable, however, the Company has not independently verified or confirmed the information and the recipient acknowledges that no representations or warranties are being made in connection with the use of the information.