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Safety Alerts
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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The information contained herein has been obtained from sources that the Company believes to be reliable, however, the Company has not independently verified or confirmed the information and the recipient acknowledges that no representations or warranties are being made in connection with the use of the information.