- Company Announcement Date:
- July 18, 2022
- FDA Publish Date:
- July 19, 2022
- Product Type:
- Reason for Announcement:
Recall Reason Description
Undeclared active pharmaceutical ingredient tadalafil
- Company Name:
- MKS Enterprise LLC
- Brand Name:
- Product Description:
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.
Product was sold through our website, wholesaleonline1.com Mar 2022 to July 2022 and distributed in any US State.
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.comhas not received any reports of adverse events related to this recall.
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.com 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
Consumers with questions may contact the wholesaleonline1.com at 201-206-0501 Monday to Friday from 9:00 AM to 6:00 PM (EDT).
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
Company Contact Information
- MKS ENTERPRISE LLC