Boost Ultra, XZone Gold, Sexy Monkey, Triple MiracleZen Platinum, Magic for Men,"New" Extenze, and New XZen Platinum Marketed as Dietary Supplements: Recall - Undeclared Drug Ingredients
ISSUE: Midwest Wholesale is voluntarily recalling the following products Boost: Ultra, XZone Gold, Sexy Monkey, Triple MiracleZen Platinum, Magic for Men, "New" Extenze, and New XZen Platinum. FDA analysis found these products to contain undeclared Sildenafil and/or Tadalafil, the active ingredients in FDA-approved prescription drugs used to treat erectile dysfunction (ED). These undeclared ingredients may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels. Men with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.
BACKGROUND: These products are labeled and intended to be used as dietary supplements for sexual enhancement. The products are packaged in 1 capsule blister packs, 3 pill bottles, 6 pill bottles, 12 pill bottles and 30 tablet boxes. These products were distributed to 20 selected retail locations in several states by Midwest Wholesale from August 1, 2013 to October, 2013. For a list of products and lot numbers included in this recall, see the Firm Press Release.
RECOMMENDATION: Consumers should stop using this product immediately and throw it away. Consumers who have experienced any negative side effects should consult a health care professional as soon as possible. Consumers with questions regarding this recall can contact Midwest Wholesale by phone (888-514-7110), Monday to Friday, 09:00am-5:00pm, Central Time.
Adverse events or side effects related to the use of these products product may be reported to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form 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.
[01/09/2014 - Firm Press Release - Midwest Wholesale]
[01/09/2014 - Product Photos]