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December 28, 1999

Spectrum Distribution & Marketing Recalls e-LUDESô Capsules

Beverly Hills, CA (SafetyAlerts) - The Food and Drug Administration (FDA) today reported that Spectrum Distribution & Marketing, Inc. is recalling e-LUDESô Capsules, in 12 count packages, because the product was marketed without an approved new drug application.

This Class III recall was initiated by the company by telephone and fax beginning November 15, 1999, followed by letter dated November 18, 1999.  This is the first public notice issued by the FDA.  The FDA considers this recall complete.

The recall affects all lots sold and distributed.  The exact distribution is not known but approximately 288 units were sent.

Questions concerning this recall may be directed to the FDA at 1-888-INFO-FDA.

Selected Recent Recalls

Health Professional:

Did you know?
During 2000 there were over
1050 products recalled in the United
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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.