May 21, 2003
Recall Update: IRON-TEK Advanced
Nutrition THERMO-TEK Capsules Recall is Complete
The Food and Drug Administration (FDA) released the following information.
THERMO-TEK Capsules, Product number 01-100, packaged in 250 cc red plastic
bottles with black ribbed
plastic caps, 120 capsules per bottle. Product was labeled in part, "***
IRON-TEK *** Advanced Performance
Nutrition *** ADVANCED FAT LOSS CATALYST *** Now Contains: Yohimbine and
Theophylline *** THERMO-TEK ***
120 CAPSULES *** Dietary Supplement *** IRON-TEK ADVANCED PERFORMANCE
NUTRITION ***. Recall # F-376-3.
All codes of IRON-TEK brand Thermo-Tek Capsules packaged
in red plastic bottles - specifically codes 2419, 2317, and other codes
distributed before January 2001
which had been contract manufactured by Horizon for IRON-TEK.
Recalling Firm: IRON-TEK Advanced Nutrition, Inc. Hauppauge, NY, by faxed
letters dated November 30, 2001,
and by mail on December 12, 2001.
Manufacturer: Horizon Pharmaceuticals Inc., St. Petersburg, FL. FDA
initiated recall is complete.
The dietary supplement contained a smaller amount of theophylline than
listed on the label.
VOLUME OF PRODUCT IN COMMERCE
Nationwide, the West Indies, and West Africa.