FDA MedWatch - Dose Vital VIP Vital Honey by MKS Enterprise
U.S. Food and Drug Administration sent this bulletin at 07/20/2022 07:35 AM EDT
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MedWatch - The FDA Safety Information and Adverse Event Reporting Program
TOPIC: Dose Vital VIP Vital Honey by MKS Enterprise: Recall - Due to Presence of Undeclared Tadalafil
AUDIENCE: Consumer, Health Professional, Pharmacy
ISSUE: This product was found to contain the undeclared active pharmaceutical ingredient tadalafil. This undeclared ingredient may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Men with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. The product was sold through the website, wholesaleonline1.com from March 2022 to July 2022 and distributed to any U.S. State.
The recall was initiated after FDA laboratory analysis confirmed that Dose Vital VIP Vital Honey contains the undeclared active pharmaceutical ingredient Tadalafil.
To date, wholesaleonline1.com 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: Tadalafil, which is a phosphodiesterase type-5 (PDE-5) inhibitor, is the active ingredient in an FDA-approved prescription drug, used to treat erectile dysfunction (ED).
RECOMMENDATIONS:
Consumers who have purchased Vital Honey on wholesaleonline1.com are urged to immediately discontinue use and return the recalled product.
Consumers with questions may contact the company.
Health professionals and consumers 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:
