TOPIC: Boom Max Capsules by Boulla: Recall - Due to the Potential Presence of Undeclared Sildenafil
AUDIENCE: Consumer, Health Professional, Cardiology, Pharmacy
ISSUE: Boulla is recalling lot number 230811, exp 8/11/25 of Boom Max capsules. Boulla was notified by Amazon that the product was 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. Products containing sildenafil cannot be marketed as dietary supplements. Boom Max is an unapproved new drug 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.
To date, Boulla has not received any reports of adverse events related to this recall.
The product was distributed via the internet and fulfilled by Amazon at www.amazon.com nationwide in the USA.
For more information about this recall/alert, click on the red button "Read Recall" below.
BACKGROUND: Boom Max is marketed as a dietary supplement for male performance and energy.
RECOMMENDATIONS:
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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 that have Boom Max capsules lot number 230881 should stop using the product.
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Consumers with questions regarding this recall can contact John Tran by phone number: 916- 619-7926 or e-mail at info@boullallc.com.
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