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Genetic Edge Compounds is voluntarily recalling GEC Laxoplex due to FDA concerns regarding the presence of anabolic steroids and other steroid-like substances. The supplement is marketed as a muscle enhancer. All lots of GEC Laxoplex distributed from February 2, 2015 through May 2, 2017 are recalled. The use of products containing anabolic steroids and other steroid-like substances is linked to acute liver injury, blood lipid abnormalities, higher risk of drug and alcohol abuse, male infertility, shrinking of testes and breast enlargement in males, masculinization in women, and short stature in children. Additionally, use of anabolic steroids is associated with increased risk of heart attack, stroke, and death. No adverse events related to this recall have been reported. The presence of these ingredients indicate that the product no longer meets the requirements of the Dietary Supplement Health and Education Act of 1994 and is therefore subject to FDA drug approval requirements.
GEC Laxoplex dietary supplements are available in nutritional supplement retail stores and websites nationwide. The supplement has the UPC code 0058049984 and comes in a white plastic bottle containing 60 capsules. Consumers should stop using this product and return it to the purchase site. Consumers may contact the manufacturer with any questions at (972) 742-6311 or brad@geneticedgecompounds.net. Report any adverse events associated with the use of this product to the FDA MedWatch Adverse Event Reporting Program.
Additional Information:
- MedWatch Safety Alert – May 8, 2017
www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm557147.htm - Genetic Edge Compounds Press Release – May 5, 2017
www.fda.gov/Safety/Recalls/ucm557125.htm