Four Firms Recall Dietary Supplements

Earlier this week we wrote that the federal government was stepping up its oversight of supplements. Now, the US Food and Drug Administration (FDA) has announced four separate <"http://www.yourlawyer.com/practice_areas/defective_drugs">supplement recalls. All of the recalls were initiated because the supplements involved might contain an Aromatase Inhibitor.

The FDA notes that potential adverse events associated with the use of Aromatase Inhibitors could include 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 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.

In all four cases, there have been no reports of adverse effects or illnesses in connection with these particular recalls.

Genetic Edge Technologies of Phoenix, Arizona
Genetic Edge recalled 60-count bottles of ArimaDex, which is sold in white bottles with orange labels containing 60 orange soft gels, was distributed throughout the US to national sports supplements distributors and could be purchased by consumers via retail stores, mail order, and internet sales. Arimadex is sold with UPC Code 718122466511 appearing on the label. All lot numbers of ArimaDex are included. onsumers who have purchased ArimaDex are urged to return it to the place of purchase for a full refund. ArimaDex can be reached at 480-248-7957 from 9:00 a.m. to 2:00 p.m.

KiloSports Inc. of Phoenix, Arizona
KiloSports is recalling 60-count bottles of Clomed, which 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 and contains 60-count white or clear capsules with the UPC Code (8 58515 00265 7 and 8 5851500096 7). All lot numbers are included. Consumers who have purchased Clomed are asked to return it to the place of purchase for a full refund. KiloSprots can be reached at 480-545-3489, from 9:00 a.m. to 5:00 p.m., Monday through Friday.

Fizogen Precision Technologies
Fizogen Precision of 3133 Fortune Way, Suite #4, Wellington, Florida, 33414 has recalled all Lot Codes of its Off Cycle II Hardcore which contains 3,17-keto-etiochol-triene (a synonym for ATD an aromatase inhibitor). Fizogen Precision Technologies is conducting this recall after being informed by representatives of the Food and Drug Administration (FDA) that they do not believe 3,17-keto-etiochol-triene meets the definition of a dietary ingredient; therefore, the product is in violation of provisions of the Food, Drug and Cosmetic Act.

Off Cycle II Hardcore was sold nationwide but discontinued by Fizogen in July of 2009. The product was sold in bottles containing 90 capsules and was manufactured exclusively for Fizogen Precision Technologies. Although the product was discontinued over a year ago, it has come to the attention of Fizogen that some online retailers may still have remaining inventory that they are offering for sale. Consumers who have Off Cycle II Hardcore in their possession should stop using it immediately and to return any unused portion to the retail location from which it was purchased or to the company directly if it was purchased from the Fizogen Precision Technologies website. Fizogen can be reached at 800-929-4099, Monday through Friday, 9:00 a.m. to 5:00 p.m., Eastern Standard Time.

Advanced Muscle Science

Advanced Muscle Science of 4590 Deodar Street, Silver Springs, Nevada 89429, issued a nationwide recall of all Lot Codes of its dietary supplement products sold under the names Arom-X, Arom-X UTT, Arom-XL, 4-AD, and Decavol, which are marketed as Natural Testosterone Boosters and Libido Enhancers. The products contain 1,4,6 etioallocholan-dione, also known as ATD, an aromatase inhibitor. These products are sold both individually and as part of promotional “Kits.” Advanced Muscle Science is conducting this recall after being informed by representatives of the Food and Drug Administration (FDA) that it is FDA’s opinion that 1,4,6 etioallocholan-dione does not meet the definition of a dietary ingredient and therefore the product is in violation of provisions of the Food, Drug and Cosmetic Act.

Arom-X Capsules had been sold nationwide, both in retail stores and direct to consumers, but were discontinued by Advanced Muscle Science in March of 2009. The product was sold in bottles containing 60 or 80 capsules, offered individually and as part of promotional “Kits” and was manufactured for Advanced Muscle Science.

Arom-X UTT Liquid had been sold nationwide, both in retail stores and direct to consumers, but was discontinued by Advanced Muscle Science in January of 2010. The product was sold as a liquid in 60mL bottles, offered individually, and as part of promotional “Kits” and was manufactured for Advanced Muscle Science.

Arom-XL Liquid had been sold nationwide, both in retail stores and direct to consumers, but was discontinued by Advanced Muscle Science in February of 2009. The product was sold in bottles containing 100 capsules and as a liquid in 120mL bottles, offered individually, and as part of promotional “Kits” and was manufactured for Advanced Muscle Science.

4-AD Capsules had been sold nationwide, both in retail stores and direct to consumers, but were discontinued by Advanced Muscle Science in March of 2009. The product was sold in bottles containing 60capsules, offered individually, and as part of promotional “Kits” and was manufactured for Advanced Muscle Science.

Decavol Capsules had been sold nationwide, both in retail stores and direct to consumers, but was discontinued by Advanced Muscle Science in January of 2010. The product was sold in bottles containing 63 capsules and was manufactured for

Advanced Muscle Science.
Although most of these products were discontinued over a year ago, it has come to the attention of Advanced Muscle Science that some online retailers may still have remaining inventory that they are offering for sale.

Consumers who have the previously described versions of Arom-X Capsules, Arom-X UTT Liquid, Arom- XL Liquid, 4-AD Capsules and Decavol Capsules in their possession should stop using them immediately. The Company is advising consumers who have Arom-X Capsules, Arom-X UTT Liquid, Arom-XL Liquid, 4-AD Capsules and Decavol Capsules to return any unused portion to the retail location from which it was purchased or if purchased directly from Advanced Muscle Science to return any unused portion to: Fitness Connection c/o AMS Fulfillment, 350 Faunce Corner Road, North Dartmouth, MA 02747; (800) 854-3891.

This voluntary recall does not include Arom-X RD, which is sold in a box of blister packs containing 60 tablets and the current version of Arom-X which is sold as a 60mL bottle, neither of which contain 1,4,6 etioallocholan-dione. Advance Muscle can be reached at 949-916-5544, Monday through Friday, 9:00 a.m. to 5:00 p.m., Pacific Standard Time.

If consumers experience any adverse side effects due to consumption of any of these products, they should contact a physician right away. Adverse reactions or quality problems experienced with the use of any of these products may be reported to Advanced Muscle Science or 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 or Fax: 1-800-FDA-0178.

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