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SafetyAlerts
May 28, 2003

High Chemical Has Recalled Sarapin Injection

(SafetyAlerts) - The Food and Drug Administration (FDA) released the following information.

PRODUCT
Sarapin Injection, Pitcher Plant, 50 ml Multiple Dose Vial, Sterile aqueous solution of soluble salts of the volatile bases. Recall # D-249-3.

CODE
Lot number - 205722 (Exp. Date 05/2005);
Lot number - 205825 (Exp. Date 05/2005);
Lot number - 206824 (Exp. Date 06/2005).

RECALLING FIRM/MANUFACTURER
High Chemical Co, Levittown, PA, by letters on April 4, 2003. Firm initiated recall is ongoing.

REASON
Lack of assurance of sterility (by manufacturer-Akorn, Inc.)

VOLUME OF PRODUCT IN COMMERCE
38,571 vials.

DISTRIBUTION
Nationwide, Canada, Switzerland, Bulgaria, and the Netherlands.

 
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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.