December 28, 1999Spectrum
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
Questions concerning this recall may
be directed to the FDA at 1-888-INFO-FDA.
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