FDA recall D-1333-2022

Product

SANGTER Energy Supplement Capsules, 3000mg x 7 grain, 7-count blister pack within a carton, Distributed by: Distributor RFR, LLC, (800) 519-0204 Miami 33172 FL, USA; UPC 0 705632 523285

Reason for recall

Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with sildenafil.

Distribution

Retail stores in the state of FL, Nationwide in the USA, France and Canada via website sales, and Bolivarian Republic of Venezuela

Key facts

Status

Terminated

Initiation date

2022-07-22

Report date

2022-08-10

Termination date

2025-07-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Doral, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1333-2022