MKS Enterprise LLC Voluntary Recalls of Dose Vital VIP Vital Honey Due to Presence of Undeclared Tadalafil
This product was found to contain the undeclared active pharmaceutical ingredient tadalafil. 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). 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 comes in a black box and contains 12 sachets of 15 grams of honey with different expiration dates stamped on the back side.
The recall was initiated after FDA laboratory analysis confirmed that Dose Vital VIP Vital Honey contains the undeclared active pharmaceutical ingredient Tadalafil.
Consumers who have purchased Vital Honey on wholesaleonline1.comExternal Link Disclaimer are urged to immediately discontinue use and return the recalled product for a full refund to: MKS Enterprise, LLC, 59 Paulison Ave. Passaic, NJ 07055
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