Aug 1, 2000"Dream On" Sleep Aid
PA (SafetyAlerts) - The Food and
Drug Administration (FDA) today reported that J.N.G. Sports Distributors is conducting a
recall of Dream On sleep aid because the product is an unapproved new drug product which
contains GBL (Gamma-Butyrolactone).
Dream On (sleep aid), OTC liquid in 16-ounce plastic bottles, marketed and used to enhance
sexual activity, improve physicial performance, reduce stress, as a sleep and widely used
as a recretional drug.
Recall #D-436-0. Class I
All lot numbers.
J.N.G. Sports Distributors, Bloomburg, Pennsylvania, by letter on April 7, 2000.
Firm-initiated recall ongoing. This is the first public notice issued by the FDA.
1,000 bottles were distributed. Firm estimated that very little to no product remained on
market at time of recall initiation.
Questions concerning this recall may be directed
to the FDA at 1-888-INFO-FDA.
Notice of this product warning was sent via email
to SafeMail subscribers August 1,
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