KiloSports Inc. of Phoenix, AZ is recalling 60 Count bottles of Clomed because it may contain an aromatase inhibitor.
KiloSports Inc. has been informed by the US Food and Drug Administration (FDA) that 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.Consumers with liver, kidney, adrenal or prostate abnormalities are at higher risk for developing adverse events. The FDA concludes that products containing aromatase inhibitors have a increased probability of developing adverse reactions in at risk consumers.
Clomed was distributed throughout the United States and could be purchased by consumers via retail stores, mail order and Internet Sales.
Clomed comes in plastic black bottles with black safety caps contains 60 Count white or clear capsules with the UPC Code (858515002657 & 858515000967). All lot numbers are being affected by this voluntary recall.
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 Clomed are asked to return it to the place of purchase for a full refund. Consumers with any questions may contact the company at 1-480-545-3489 9AM – 5PM Monday - Friday.
Adverse reaction or quality problems experienced with the use of this product 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.