Marketed as Dietary Supplement

  • Undeclared Sildenafil and Diclofenac
  • Company: Boulla LLC
  • Dietary Supplements, Drugs
  • FDA
  • November 4, 2024

Product details

  • Marketed as Dietary Supplement

Company announcement

Boulla LLC is voluntarily recalling ZoomMax and ZapMax Capsules due to the presence of undeclared sildenafil and diclofenac.

The product was distributed via the internet on Amazon.com in the USA.

Lot number YZM240406 should stop using the product.

No adverse events have been reported to date.

Risk:

Consumption of products with undeclared sildenafil may 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. Use of products with undeclared diclofenac may cause increased risk of cardiovascular events, such as heart attack and stroke, as well as serious gastrointestinal damage, including bleeding, ulceration, and fatal perforation of the stomach and intestines. This hidden drug ingredient may also interact with other medications and significantly increase the risk of adverse events, particularly when consumers use multiple NSAID-containing products.

Impacted states: Nationwide

Products:

- ZoomMax Capsules

- ZapMax Capsules

Contact

For more information, email boullallc@proton.me.

View the original FDA notice

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