MedWatch - The FDA Safety Information and Adverse Event Reporting ProgramGEC Laxoplex Dietary Supplement Capsules by Genetic Edge Compounds: Recall - Presence of Anabolic SteroidsAUDIENCE: Consumer ISSUE: Genetic Edge Compounds recalled all lot codes of GEC Laxoplex dietary supplement capsules distributed between February 2, 2015- May 2, 2017 to the retail level and consumer level. FDA analysis found GEC Laxoplex to be tainted with anabolic steroids and steroid like substances. The presence of these anabolic steroids and steroid like substances in GEC Laxoplex renders it an unapproved drug for which safety and efficacy have not been established and therefore subject to recall. Use or consumption of products containing anabolic steroids may cause acute liver injury, which is known to be a possible harmful effect of using steroid containing products. In addition, abuse of anabolic steroids may cause other serious long-term adverse health consequences in men, women, and children. These include shrinkage of the testes and male infertility, masculinization of women, breast enlargement in males, short stature in children, a higher predilection to misuse other drugs and alcohol, adverse effects on blood lipid levels, and increased risk of heart attack, stroke, and death. BACKGROUND: GEC Laxoplex is marketed as a dietary supplement and sold as a muscle enhancing agent. The product is packaged in a white plastic bottle containing 60 capsules with UPC code 0058049984 and can be identified by GEC Laxoplex. The recall affects all lots of GEC Laxoplex. GEC Laxoplex was distributed Nationwide in the USA through various nutritional supplement retail outlets. RECOMMENDATION: Genetic Edge Compounds is notifying its retailers and customers by a formal recall notification and is arranging for a return of all recalled products. Consumers and retailers that have GEC Laxoplex dietary supplement capsules which are being recalled should stop using them and return to place of purchase. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
Read the MedWatch safety alert, including a link to the firm's press release, at: You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm Update your subscriptions, modify your e-mail address, or stop subscriptions at any time on your Subscriber Preferences Page. You will need to use your email address to log in. If you have questions or problems with the subscription service, please visit subscriberhelp.govdelivery.com. This service is provided to you at no charge by U.S. Food & Drug Administration (FDA).
|
