Company Announcement Date: November 08, 2019
FDA Publish Date: November 08, 2019
Product Type: Drugs
Reason for Announcement: Product is tainted with sildenafil
Company Name: Med Man Distribution
Brand Name: Up2
Product Description: Up2 THERE IS NO OTHER All Natural Libido for Men & Women Dietary Supplement
Med Man Distribution is voluntarily recalling all lots of Up2 Dietary supplement There is no other all-natural libido for men and women to the consumer level.
FDA laboratory analysis has found Up2 Dietary supplement. There is no other all natural libido for men and women to be tainted with sildenafil. Sildenafil is an FDA-approved prescription drug for erectile dysfunction. The presence of sildenafil in Up2 products renders them unapproved drugs for which safety and efficacy have not been established, therefore subject to recall.
This undeclared ingredient may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels which can be life threatening. People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates and may be the population most likely to be affected. To date, Med Man has not received any reports of adverse events related to this recall.
The affected Up2 Dietary supplement There is no other all natural libido for men and women lots include [240 ten count units upc is 85606300322 and 480 four count packages upc 856063006315 and 960 singlepack units] upc 856063006308. Up2 was distributed in the USA to Regal Labs and to their nationwide retailers.
Med Man is notifying its distributors and their customers by written email and is arranging for destruction of all recalled products. Consumers that have Up2 Dietary supplement There is no other all natural libido for men and women which is being recalled should stop using and stop using and return to retailer for refund.
Consumers with questions regarding this recall can contact Med Man by calling 705-297-5321 Monday to Friday eastern time zone 9 am to 5pm or email@example.com. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug 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.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.