December 14, 1999
Updated May 24, 1999Rugby Hemorrhoid Preparation
Norcross, GA (SafetyAlerts) - The Food and Drug
Administration (FDA) today reported that Rugby Laboratories is recalling Rugby Hemorrhoid
Preparation Suppositories because the product lacks pregnancy-nursing warning.
This ongoing Class II recall was initiated by
the company, by letter on August 26, 1999. This is the first notice the FDA has issued to
the general public of the recall. The firm estimated that 250 boxes remained on
market at time of recall initiation.
Approximately 1200 cardboard boxes
containing 12 suppositories of the recalled medication, manufactured by Hi-Tech Pharmacal,
was distributed for sale over the counter in Georgia, Indiana, Kentucky, Michigan, North
Carolina, New Jersey, Ohio, Oregon, Pennsylvania and Texas. This recall affects Lot
On May 24, 2000 this
recall was extended to include Lot #908222.
Questions concerning this recall may
be directed to the FDA at 1-888-INFO-FDA.
Notice of this product warning update
was sent via email to SafeMail
subscribers May 24, 2000.
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