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SafetyAlerts
February 7, 2003

Novex Pharma Has Recalled Clemastine Fumarate Syrup

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

PRODUCT
Clemastine Fumarate Syrup, 0.5mg/5mL, Each teaspoonful (5mL) contains clemastine 0.5 mg (present as clemastine fumarate 0.67 mg) and alcohol 5.5%, 4 fluid ounces (118 mL) bottles, Rx only. Recall # D-108-3.

CODE
Lot number 1A950, exp. 02 2003.

RECALLING FIRM/MANUFACTURER
Novex Pharma, Richmond Hill, CA, by letter on November 19, 2002. Firm initiated recall is ongoing.

REASON
Degradation; product exceeds specification at 18 month timepoint.

VOLUME OF PRODUCT IN COMMERCE
2,083 bottles.

DISTRIBUTION
Nationwide.

 

 
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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.