September 14, 1999
Compazine Spansule (Prochlorperazine Maleate)
Recalled by SmithKline Beecham
Philadelphia, PA (SafetyAlerts) - The Food and Drug
Administration (FDA) today reported that SmithKline Beecham is recalling Compazine
Spansule because of release rate failure.
Compazine Spansule (prochlorperazine Maleate), Rx,
used to control severe nausea and vomiting:
a) 10 mg, in botles of 50 capsules. NDC #0007-3344-15;
b) 15 mg bottles of 50 capsules and 4 capsule unit boxes.NDC
#0007-3346-15 and 0007-3346-67.
Recall #D-406/407-9. Class II
All lots on the market.
SmithKline Beecham Pharmaceuticals, Philadelphia, Pennsylvania.
Manufacturer, by letter on July 30, 1999, and by telephone on July 28, 1999.
Firm-initiated recall ongoing.
Firm estimated that 60,000 bottles of 50 capsules and 80,000 boxes of 4 capsules
remained on market at time of recall initiation.
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