Genetic Edge Technologies of Phoenix, Arizona is voluntarily recalling 60 count bottles of ArimaDex and KiloSports Inc., also of Phoenix, is recalling 60 count bottles of Clomed, because they may contain an Aromatase Inhibitor.
Both Genetic Edge Technologies and KiloSports, Inc. have been informed by the US Food and Drug Administration (FDA) that potential adverse events associated with the use of aromatase inhibitors could include the following: decreased rate of bone maturation and growth, decreased sperm production, infertility, aggressive behavior, adrenal insufficiency, kidney failure, and liver dysfunction.
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Consumers with liver, kidney, adrenal, or prostate abnormalities are at a potentially higher risk for developing adverse events. The FDA concludes that products containing aromatase inhibitors have an increased probability of developing adverse reactions in at risk consumers.
Both ArimaDex and Clomed were distributed throughout the United States to national sports supplements distributors and could be purchased by consumers via retail stores, mail order and internet sales.
Arimadex comes in white bottles with orange labels containing 60 orange soft gels. Arimadex is sold with UPC Code 718122466511 appearing on the label. All lot numbers of ArimaDex are being affected by this voluntary recalled.
Clomed comes in plastic black bottles with black safety caps contains 60 Count white or clear capsules with the UPC Code (8 58515 00265 7 & 8 5851500096 7 ) All lot numbers are being affected by this voluntary recall.
Genetic Edge technologies has received no reports of any types of any adverse event or illnesses since first marketing ArimaDex in Feb 2009. KiloSports Inc. has received no reports of any adverse effects or Illness of any type since first marketing Clomed since 2005.
Consumers who have purchased either product are urged to return it to the place of purchase for a full refund. Consumers with questions about ArimaDex may contact the company at 1-480-248-7957 during the hours of 9AM – 2PM M-F; customers with questions about Clomed may contact the company at 1.480.545.3489 9AM – 5PM M-F.
Adverse reaction or quality problems experienced with the use of these products may be reported to the FDA’s MedWatch Adverse Event Reporting program online, by regular mail, or by fax. Online: www.fda.gov/MedWatch/report.htm. Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form. Fax: 1-800-FDA-0178.