- Company Announcement Date:
- February 24, 2020
- FDA Publish Date:
- February 24, 2020
- Product Type:
- Dietary Supplements
- Reason for Announcement:
Recall Reason Description
Product is tainted with sildenafil
- Company Name:
- Med Man Distribution
- Brand Name:
Up2 and Bow & Arrow
- Product Description:
Up2 THERE IS NO OTHER All Natural Libido for Men & Women Dietary Supplement and Bow and Arrow libido enhancer for men
On 11/8/2019, Med Man Distribution voluntarily recalled all lots of Up2 dietary supplement. The recall has expanded to include all lots of dietary supplement Bow and Arrow libido enhancer for men to the consumer level.
FDA laboratory analysis has found Up2 Dietary supplement and Bow and Arrow to contain undeclared sildenafil. Sildenafil is an FDA-approved prescription drug for erectile dysfunction. The presence of sildenafil in Up2 and Bow and Arrow 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.
All lots and UPCs of Up2 and Bow and Arrow are being recalled and are listed in the table below:
|UP2, ten count units||030419||85606300322|
|UP2, four count units||030419||856063006315|
|UP2, single count units||030419||856063006308|
|Bow and Arrow, ten count units||0217||5706300632|
|Bow and Arrow, four count units||0217||5706300631|
Bow & Arrow libido enhancer and Up2 dietary supplement were 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 Bow & Arrow libido Enhancer for men should 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 protected]. 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.
- 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
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Link to Original Recall