February 7, 2003
Novex Pharma Has Recalled Clemastine
The Food and Drug
Administration (FDA) released the following information.
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.
Lot number 1A950, exp. 02 2003.
Novex Pharma, Richmond Hill, CA, by letter on November 19, 2002. Firm
initiated recall is ongoing.
Degradation; product exceeds specification at 18 month timepoint.
VOLUME OF PRODUCT IN COMMERCE