News

Copyright © 2018 Natural Medicines (www.naturalmedicines.com)
November 2013

FDA: Hidden Ingredients Prompt Recall of Multiple Sexual Enhancement Supplements

The U.S. Food and Drug Administration recently issued several press releases announcing the recalls of multiple sexual enhancement products due to undeclared ingredients.

The recalled products include RezzRX, Rhino 5 Plus, Maxtremezen, Extenzone, P-Boost, and NatuRECT.

Fossil Fuel Products, LLC, issued a voluntary recall of the following lots of RezzRX: QL110714A102 (20-count white bottles containing yellow capsules, expiring November 2013) and QL110408B046 (single blister packs containing one yellow capsule, expiring June 2015). RezzRX is a product that is marketed as a natural sexual enhancement supplement. The product was distributed nationwide via numerous websites and retail stores in Georgia. The recall is due to the finding that these lots of RezzRX contain hydroxylthiohomosildenafil and amionotadalafil, which are active ingredients of FDA-approved drugs for erectile dysfunction (ED).

Jobbers Wholesale issued a voluntary recall of the following lots: lot number KWAKPMC030505175957019 of Rhino 5 Plus, lot number JBP-L-1270-70 of Maxtremezen, and lot number KWAKPMC03050517 of Extenzone. These three products are marketed as dietary supplements to be used for sexual enhancement, and are available in blister packs each containing one capsule. The products were distributed to select retail customers in California between June and November of this year. The recall is due to the finding that these lots contain the undeclared ingredients desmethylcarbondenafil, an unapproved drug for erectile dysfunction, and dapoxetine, an active ingredient not approved by the FDA.

Tendex issued a voluntary recall of the following lots: Lot# F51Q of P-Boost and Lot # F51Q of NatuRECT. The products are labeled for use as dietary supplements for sexual enhancement and come in single capsule blister packs, as well as bottles containing 5-40 capsules. Both products have been distributed nationwide on websites and to retail stores. The products were found to contain tadalafil, an active ingredient of FDA-approved drugs used to treat erectile dysfunction.

The press releases state that these undeclared ingredients may post a threat to consumers' health, particularly in people who take prescription drugs that contain nitrates. Those who have diabetes, high blood pressure, heart disease, or high cholesterol often take nitrates.

Consumers are advised to contact the manufacturers with questions, and to speak to a doctor or other healthcare provider if they have experienced any problems related to the use of these products. Any side effects possibly caused by these products should be reported to the FDA's MedWatch Adverse Event Reporting program.

References

  1. Natural Standard: The Authority on Integrative Medicine. 
  2. US Food and Drug Administration. www.fda.gov

The information in this brief report is intended for informational purposes only, and is meant to help users better understand health concerns. This information should not be interpreted as specific medical advice. Users should consult with a qualified healthcare provider for specific questions regarding therapies, diagnosis and/or health conditions, prior to making therapeutic decisions. Copyright © 2018 Natural Medicines Inc. Commercial distribution or reproduction prohibited. Natural Medicines is the leading provider of high-quality, evidence-based, clinically-relevant information on natural medicine, dietary supplements, herbs, vitamins, minerals, functional foods, diets, complementary practices, CAM modalities, exercises and medical conditions. Monograph sections include interactions with herbs, drugs, foods and labs, contraindications, depletions, dosing, toxicology, adverse effects, pregnancy and lactation data, synonyms, safety and effectiveness.