May 11, 2001Heart-Trex Tablets Recalled
MA (SafetyAlerts) - The Food and
Drug Administration (FDA) said today that Otis Clapp & Son, Inc. has recalled
Heart-Trex Tablets because the product was distributed without an approved new drug
application for the cardiovascular related uses represented in the labeling, and because
it bears no dosage direction for use in pain and fever relief.
This is the first public notice of
this Class III
recall issued by FDA.
a) Safety Pack Boxes (250 Packets of 2);
b) C577 Unit boxes of 8X2 Packets
Otis Clapp & Son, Inc., Canton, MA.
Manufacturer, via fax and overnight mail on 4/18/01. Firm-initiated recall ongoing.
AL, FL, GA, IN, KY, MA, NC, NJ, NY, NV, OH, OR, PA, TN, TX and WA.
Safety Pack: 320 boxes C577 Units: 297 boxes.
Questions concerning this recall may be directed
to the FDA at 1-888-INFO-FDA.