TOPIC: Magnum XXL 9800 Capsules by Meta Herbal: Recall - Due to Presence of Undeclared Sildenafil
AUDIENCE: Consumer, Health Professional, Pharmacy
ISSUE: Meta Herbal is recalling Magnum XXL 9800 2000 mg per capsule because the products have been found to be tainted with sildenafil. Sildenafil is an ingredient known as a phosphodiesterase inhibitor (PDE-5) found in FDA-approved products for the treatment of male erectile dysfunction. Products containing sildenafil cannot be marketed as dietary supplements. Magnum XXL 9800 capsules is an unapproved new drug for which safety and efficacy has not been established and, therefore, subject to recall.
Risk Statement: 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, Meta Herbal 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: The tainted product is marketed as a dietary supplement for male sexual enhancement. The product was distributed and sold online on Amazon.
RECOMMENDATIONS:
- 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.
- Consumers that have the recalled product should stop using and contact Meta Herbal for return/refund instructions.
- Consumers with questions regarding this recall can contact Meta Herbal.
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