Drug 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

D-1333-2022

July 22, 2022

Class I

Product summary

Firm: Distributor RFR, LLC.
Event: Event 90675
Status: Terminated
Classification: Class I
Quantity: 2000 cartons
Official record key: drug-enforcement:D-1333-2022

Official wording

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

Code information: Lot: 48656, Exp. 01/2025

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

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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