Clemastine Fumarate Syrup Recall

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SafetyAlerts
February 7, 2003

Novex Pharma Has Recalled Clemastine Fumarate Syrup

(Clemastine Fumarate Syrup is a Tavist Generic.)

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.