Summary

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Company Announcement

FOR IMMEDIATE RELEASE – November 28, 2023 – E. Hampton NY- Meta Herbal is voluntarily recalling 500 blister packs of Magnum XXL 9800 2000 mg per capsule, to the consumer level. 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.

The tainted product is marketed as a dietary supplement for male sexual enhancement and is packaged in blister packs of one pill, with a UPC 6 45759 99300 7 exp 1/2025.. Each blister pack is sold individually and holds one capsule. Product was distributed and sold online on Amazon under the ASINs: B07P7ZH797, B07P94J3ZT, B07P6VK6N3, B076HNPZZZ.

Meta Herbal is notifying its customers via Amazon and is arranging for refunds. All blister packs of Magnum XXL 9800 are affected by this recall. 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 by e-mail: info@metaherbal.com 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.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online
• Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

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