January 22, 2001ADCON® 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
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.
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