Genetic Edge Compounds Issues Voluntary Nationwide Recall of GEC Laxoplex Dietary Supplement Capsules Due to Presence of Anabolic Steroids
- Company Announcement Date:
- May 05, 2017
- FDA Publish Date:
- February 09, 2019
- Product Type:
- Reason for Announcement:
- Company Name:
- Genetic Edge Compounds
- Brand Name:
Brand Name(s)GEC Laxoplex
- Product Description:
Product DescriptionMarketed as a dietary supplement
Genetic Edge Compounds is voluntarily recalling all lot codes distributed between February 2, 2015- May 2, 2017 of GEC Laxoplex dietary supplement capsules, packaged in a white plastic bottle containing 60 capsules to the retail level and consumer level. Food and Drug Administration (“FDA”) analysis has 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. To date, Genetic Edge Compounds has not received any reports of these or any other adverse effects related to this recall.
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.
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.
This recall is being conducted due to the presence of ingredients that the FDA has stated do not meet the requirements of the Dietary Supplement Health and Education Act of 1994. It is FDA’s position that the ingredients in the products are not properly dietary ingredients that may be present in dietary supplements. Genetic Edge Compounds’ decision to implement this recall should not be construed as an admission that its sale of this product was in violation of the law. Genetic Edge Compounds is undertaking this voluntary recall solely out of an abundance of caution and in deference to FDA’s concerns.
Consumers with questions regarding this recall can contact Genetic Edge Compounds by phone at (972) 742-6311 or by email email@example.com on Monday through Friday from 9 am to 5 pm Central Standard Time. Consumers should contact their physician or healthcare provider if they have experienced any adverse effects.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.