FDA MedWatch - Kingdom Honey Royal Honey VIP by Shopaax.com

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TOPIC: Kingdom Honey Royal Honey VIP by Shopaax.com: Recall - Due to Presence of Undeclared Sildenafil

AUDIENCE: Consumer, Health Professional, Pharmacy

ISSUE: Shopaax.com is recalling all lots of Kingdom Honey Royal Honey VIP because it contains undeclared sildenafil, the active ingredient in the FDA-approved prescription drug Viagra, used to treat erectile dysfunction. FDA approval of Viagra is restricted to use under the supervision of a licensed health care professional. Use of products with the undeclared active ingredient may pose a threat to consumers because the active ingredient 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 these products, adult males who use nitrates for cardiac conditions are at the most at risk from these products.

The recall was initiated after FDA laboratory analysis confirmed that Kingdom Honey Royal Honey VIP contains sildenafil, the active ingredient in the FDA-approved prescription drug Viagra.

Selling of this product has been suspended on Shopaax.com has temporary removed all other products on the website pending investigation. 

For more information about this recall, click on the red button "Read Recall" below.

BACKGROUND: The product being recalled is promoted and sold for sexual enhancement on various websites and possibly in some retail stores.

RECOMMENDATIONS: 

• Consumers who have purchased Kingdom Honey Royal Honey VIP are urged to immediately discontinue use and return recalled product.
• Consumers with questions may contact the company.
• Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.

Consumers and health professionals are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report online.
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

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