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SafetyAlerts
May 11, 2001

Heart-Trex Tablets Recalled

Canton, 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.

PRODUCT
Heart-Trex Tablets.

Recall #D-197-1.

CODE:
a) Safety Pack Boxes (250 Packets of 2);
b) C577 Unit boxes of 8X2 Packets
All lots.

MANUFACTURER:
Otis Clapp & Son, Inc., Canton, MA.

RECALLED BY:
Manufacturer, via fax and overnight mail on 4/18/01. Firm-initiated recall ongoing.

DISTRIBUTION:
AL, FL, GA, IN, KY, MA, NC, NJ, NY, NV, OH, OR, PA, TN, TX and WA.

QUANTITY:
Safety Pack: 320 boxes C577 Units: 297 boxes.

Questions concerning this recall may be directed to the FDA at 1-888-INFO-FDA.

 
Selected Recent Recalls


Health Professional:

Did you know?
During 2000 there were over
1050 products recalled in the United
States for safety reasons!

How many did you hear about?

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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.