Distributor RFR, LLC, Voluntary Nationwide Recall of Sangter Energy Supplement Due to Presence of Undeclared Sildenafil

Summary

Company Announcement

08/01/2022 – Miami, Florida, DISTRIBUTOR RFR, LLC. is voluntarily recalling lot #48656, Exp. 01/2025 of SANGTER Energy Supplement, 3000 mg, packaged in 7-count blister packs within a carton to the consumer level. FDA analysis has found the product to contain undeclared sildenafil. Sildenafil is a phosphodiesterase (PDE-5) inhibitor found in FDA-approved products for the treatment of male erectile dysfunction. The presence of sildenafil in SANGTER makes it an unapproved new drug for which the safety and efficacy has not been established and, therefore subject to recall.

Risk Statement: Use of SANGTER with undeclared sildenafil may pose a threat to consumers because it 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. To date, DISTRIBUTOR RFR, LLC. has not received any reports of adverse events related to this recall.

The tainted product is marketed as a dietary supplement for male sexual enhancement and is packaged in a 7-count blister pack within a carton, UPC 0 705632 523285, and was distributed through retail stores in the state of Florida from 02/01/2002 to 07/20/2022 and Nationwide in the USA through our website from 02/01/2002 to 07/20/2022  www.sangter.com.

Distributor RFR, LLC is notifying its distributors and customers through this notice and is arranging for the return of all recalled products. Consumers with questions about this recall can contact us via email at [email protected] or by phone at (305) 989-5472, Monday- Friday, from 8:00AM-5PM (EDT). All customers are urged to stop consuming the product marked with this lot, and to contact their physician or health care provider if they have experienced any problems that may be related to taking or using this medication.

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.