June 13, 2000Glaxo Wellcome Recalls
NC (SafetyAlerts) - The Food and
Drug Administration (FDA) today reported that Glaxo Wellcome is conducting a recall of
Imitrex(r) (sumatriptan succinate) Rx tablets, 25 mg, in 9-tablet units, because the
blister text incorrectly declares product strength at 50 mg (outer carton is correctly
labeled at 25 mg.
According to FDA this recall affects
the lot numbers of OZP0151 and OZP0152 (NDC #0173-0460-02). About 27,600 units were
This ongoing Class III recall
was initiated by the company, by letter on April 28, 2000. This is the first public
notice issued by the FDA.
Questions concerning this recall may
be directed to the FDA at 1-888-INFO-FDA.
FDA Recall #D-393-0
Notice of this product warning was
sent via email to SafeMail
subscribers June 13, 2000.
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