Recall notice
Male Enhancement Dietary Supplements recalled due to Undeclared Ingredients, USA
8 months ago •source fda.gov
United States
HEALTH FIXER is voluntarily recalling all lots of dietary supplements by the name of Male Ultra, Malextra, Electro Buzz, Ultra Armor and Male Ultra Pro- blister packs of 10 capsules per box/carton to the consumer level. Laboratory analysis has found the products to be tainted with chloropretadalafil, propoxyphenylsildenafil, and sildenafil. Health Fixer's supplements were distributed Nationwide across the U.S to Amazon Online Shopping.Sildenafil is an ingredient in FDA approved products for treatment of male erectile dysfunction in the family of drugs known as phosphodiesterase (PDE-5) inhibitors. Chloropretadalafil and propoxyphenylsildenafil are analogues of PDE-5 inhibitors and are likely to carry the same clinical risks. Products containing chloropretadalafil, propoxyphenylsildenafil, and sildenafil cannot be marketed as dietary supplements. These products are unapproved new drugs for which safety and efficacy have not been established and, therefore, subject to recall.
Risk Statement: Consumption of products with undeclared PDE-5 interact with nitrates found in some prescription drugs (such as nitroglycerin) and may cause a significant drop in blood pressure that may be life threatening. People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Among the adult male population, who are most likely to use this product, adult males who use nitrates for cardiac conditions are most at risk.
The tainted capsules are marketed as dietary supplements used as male enhancement products and are packaged in
The products are used as an oral supplement and are packaged in blister packs containing 10 units of capsules, with the associated codes as follows:
- Product Name: Male Ultra
- NDC/UPC: B0CMQ4FTHG
- Lot Numbers: KT-1ST-43-0110-2025
- Expiration: 01/10/2027
- Product Name: Malextra
- NDC/UPC: B0CWKZ6ZP3
- Lot Numbers: KT-1ST-43-0104/2026
- Expiration: 04/25/2026
- Product Name: Electro Buzz
- NDC/UPC: B0DK68LF6J
- Lot Numbers: KT-1ST-43-0107/2024
- Expiration: 10/15/2026
- Product Name: Ultra Armor
- NDC/UPC: B0CYJ7Y5H9
- Lot Numbers: KT-1ST-43-0110/2025
- Expiration: 01/10/2027
- Product Name: Male Ultra Pro
- NDC/UPC: B0CZN7C6YH
- Lot Numbers: KT-1ST-43-0110/2025
- Expiration: 03/15/2026
Consumers are advised not to sue the product and to return it to where they purchased it.
Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/health-fixer-issues-voluntary-nationwide-recall-male-ultra-malextra-electro-buzz-ultra-armor-and
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