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June 13, 2000

Glaxo Wellcome Recalls Imitrex(r) Tablets

Zebulon, 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 distributed nationwide.

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.

Selected Recent Recalls

Health Professional:

Did you know?
During 2000 there were over
1050 products recalled in the United
States for safety reasons!

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