April 5, 2000Cafergot® Suppositories
East Hanover, NJ (SafetyAlerts) - The Food and Drug
Administration (FDA) today reported that Novartis Pharmaceuticals Corporation is recalling
Cafergot Suppositories because of subpotency - Ergotamine at 6-month stability testing.
The Cafergot Suppositories
(ergotamine tartrate USP .2mg/caffeine USP 100 mg), is a prescription indicated as therapy
to abort or prevent vascular headache. NDC #0078-0033-02.
According to the FDA, approximately
4,900 cartons were distributed nationwide and bear the lot number of 130B9188 EXP
4/01. The firm estimated that 5% or less remained on market at time of recall initiation.
This ongoing Class III recall
was initiated by Novartis Pharmaceuticals Corporation, by fax and mail on February 9,
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-255-0
Notice of this product warning was
sent via email to SafeMail
subscribers April 5, 2000.
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