Pharmacy Services

Recall of Dietary Supplement Products Containing Aromatase Inhibitors

September 20, 2010

Several dietary supplements marketed for hormonal regulation and athletic performance contain undeclared, potentially harmful ingredients. These products may contain ATD, an aromatase inhibitor which is not approved in the US and cannot be appropriately defined as a dietary supplement. Although several of these products were discontinued some time ago, FDA and the manufacturers recently learned that inventory may still be available from online retailers. All lots of the following products have been voluntarily recalled by the manufacturers at the FDA’s request:

  • Reversitol capsules from iForce Nutrition: Sold in 60-count red bottles with white cap. Product discontinued in December 2009.
  • Off Cycle II Hardcore capsules from Fizogen Precision Technologies: Sold in 90-count bottles. Product discontinued in July 2009.
  • AROM-X capsules from Advanced Muscle Science: Sold in 60- and 80-count bottles, alone and in promotional packages. Product discontinued in March 2009.
  • AROM-X UTT liquid from Advanced Muscle Science: Sold in 60-mL bottles, alone and in promotional packages. Product discontinued in January 2010.
  • AROM-XL liquid from Advanced Muscle Science: Sold in 100-count bottles as capsules and in 120-mL bottles as liquid, alone and in promotional packages. Product discontinued in February 2009.
  • 4-AD capsules from Advanced Muscle Science: Sold in 60-count bottles, alone and in promotional packages. Product discontinued in March 2009.
  • Decavol capsules from Advanced Muscle Science: Sold in 63-count bottles, alone and in promotional packages. Product discontinued in January 2010.
  • ArimaDex soft gels from Genetic Edge Technologies: Sold in 60-count white bottles with orange labels, UPC Code 718122466511.
  • Clomed capsules from KiloSports: Sold in 60-count black bottles with black caps, UPC Codes 858515002657 and 858515000967.

ATD (also called 6-etioallochol-1,4-diene-3,17-dione; 3,17-keto-etiochol-triene; or 1,4,6 etioallocholan-dione) may cause harm to the patient. Other aromatase inhibitors (eg, anastrozole, letrozole) are approved in the US for prescription use only. Side effects of aromatase inhibitors may include slower bone maturation / growth, decreased production of sperm, infertility, aggression, adrenal insufficiency, renal failure, and hepatic dysfunction. Risk of adverse events may be higher in patients with underlying organ dysfunction, adrenal disease, or prostate disorders.

Educate patients not to use the listed products and if they have already used them, to consult their healthcare provider immediately. Consumers should return any unused product, following the instructions for the specific manufacturer:

  • iForce (Reversitol): return unused product to the place of purchase. If purchased directly from iForce Nutrition, return to 1305 Hot Spring Way #103, Vista, CA 92081, Attention: Reversitol Recall. For additional information, contact iForce at 877-743-6460, weekdays from 9AM to 5PM Pacific Standard Time. Note that Reversitol V2 is not affected by this recall.
  • Fizogen (Off Cycle II Hardcore): return unused product to the place of purchase. If purchased directly from Fizogen, return to 3133 Fortune Way, Suite #4, Wellington, FL 33414. For additional information, contact Fizogen at 800-929-4099 or pat@fizogen-hq.com, weekdays from 9AM to 5PM Eastern Standard Time.
  • Advanced Muscle Science (Arom-X capsules, Arom-X UTT liquid, Arom- XL liquid, 4-AD capsules, Decavol capsules): return unused product to the place of purchase. If purchased directly from the manufacturer, return to Fitness Connection, c/o AMS Fulfillment, 350 Fauncer Corner Road, North Dartmouth, MA 02747. For additional information, contact the company at 800-854-3891, weekdays from 9AM to 5PM Pacific Standard Time. Note that Arom-X RD 60-count tablets and Arom-X liquid in 60-mL bottles are not affected by this recall.
  • Genetic Edge Technologies (ArimaDex): return unused product to the place of purchase for a full refund. For additional information, contact the company at 480-248-7957, weekdays from 9AM to 2PM Arizona Time.
  • KiloSports (Clomed): return unused product to the place of purchase for a full refund. For additional information, contact the company at 480-545-3489, weekdays from 9AM to 5PM Arizona Time.

Additional information is available at the following links:

Updated
September 20, 2010; University of Utah, Drug Information Service. Copyright 2010, Drug Information Service, University of Utah, Salt Lake City, UT.