For Immediate Release
November 29, 2016
ConsumersMS Bionic Customer Service
MS Bionic, Inc. announced today that it is conducting a voluntary nationwide recall of all lots of Megajex Natural Male Sex Enhancer capsules. FDA analysis has found the product to contain Tadalafil and Sildenafil. Tadalafil and Sildenafil are FDA-approved drugs used as treatment for male Erectile Dysfunction (ED). The active drug ingredients are not listed on the label for this product. To date, no adverse events have been reported.
Megajex Natural Male Sex Enhancer is marketed as a dietary supplement for erectile dysfunction. It is packaged in 20 count bottles and sold nationwide.
Use of this product may pose a threat to consumers because the undeclared active ingredients may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. ED is a common problem in men with these conditions, and consumers may seek these types of products to enhance sexual performance.
MS Bionic, Inc. advises any customers in possession of the Megajex to stop using and return any unused product for a full refund to the company directly. Customers can call 714-470-4352 between the hours of 10 a.m. and 5 p.m. Pacific Standard Time for instructions on the return and refund process. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.
MS Bionic, Inc. is committed to improving its products and avoiding future recall issues by sourcing higher quality raw ingredients and expanding testing. MS Bionic, Inc. promises its customers the highest possible quality and welcomes the recall process as further evidence of our commitment to our brands, products and consumers.
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.