SANGTER Energy Supplement Capsules, 3000mg x 7 grain, 7-count blister pack within a carton, Distr...

FDA Recall #D-1333-2022 — Class I — July 22, 2022

Recall #D-1333-2022 Date: July 22, 2022 Classification: Class I Status: Terminated

Product Description

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.

Recalling Firm

Distributor RFR, LLC. — Doral, FL

Classification

Class I — Reasonable probability of serious adverse health consequences or death.

Product Type

Drugs

Product Quantity

2000 cartons

Distribution

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

Code Information

Lot: 48656, Exp. 01/2025

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated