MKS Enterprise LLC is recalling Dose Vital VIP Vital Honey after the product was found to contain the undeclared active pharmaceutical ingredient tadalafil, an FDA-approved prescription drug, used to treat erectile dysfunction (ED).
The recall was initiated after FDA laboratory analysis confirmed that Dose Vital VIP Vital Honey contains the undeclared active pharmaceutical ingredient Tadalafil.
The FDA sent a warning letter to the company, as well as three other honey companies, about the presence of active drug ingredients in their products. Shopaax.com also recalled all lots of Kingdom Honey Royal Honey VIP because it contains undeclared Sildenafil last week.
FDA approval of Viagra is restricted to use under the supervision of a licensed health care professional. The 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.
Recalled product:
- The product was sold on wholesaleonline1.com, March-July 2022, and distributed to all U.S. states.
- 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.
To date, wholesaleonline1.com has not received any reports of adverse events related to this recall.
Consumers who have purchased the recalled product 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.
Have you had a reaction to this 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
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