TOPIC: ZoomMax and ZapMax Capsules by Boulla: Recall - Due to the Presence of Undeclared Sildenafil and Diclofenac
AUDIENCE: Consumer, Health Care Professional, Cardiology
ISSUE: Boulla LLC is recalling lot YZM240406, of ZoomMax Capsules and ZapMax Capsules packaged in 10-count blisters because the products were found to be tainted with sildenafil, an ingredient in FDA approved products for treatment of male erectile dysfunction in the family of drugs known as phosphodiesterase (PDE-5) inhibitors and diclofenac, an FDA approved drug known as a nonsteroidal anti-inflammatory drug (NSAID) used to treat pain and inflammation. Products containing sildenafil and diclofenac cannot be marketed as dietary supplements. ZoomMax and ZapMax capsules are unapproved new drugs for which safety and efficacy have not been established and, therefore, subject to recall.
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.
The product was distributed via the internet on Amazon.com in the USA.
To date, Boulla LLC has not received any reports of adverse events related to this recall.
For more information about this recall, click on the red button "Read Recall" below.
BACKGROUND: ZoomMax capsules and ZapMax capsules are marketed as dietary supplements for male performance and energy.
RECOMMENDATIONS:
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Consumers that have ZoomMax or ZapMax capsules lot number YZM240406 should stop using the product.
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Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
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Consumers with questions regarding this recall can contact Boulla LLC via e-mail at boullallc@proton.me.
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