FITOTERAPIA USA, INC recalls Mero Macho Artificially Flavored Passion Fruit Vitamin C Liquid Supplement, 2.04 fl oz (60 mL) bottle, Manufactured By:…

Recall date

September 16, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0320-2020

FDA classification

Class I

Brand / firm

FITOTERAPIA USA, INC

Sold / distributed

FL, PA, NY and Canada

Why it was recalled

Marketed without an approved NDA/ANDA: Product found to be tainted with Tadalafil.

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

Mero Macho Artificially Flavored Passion Fruit Vitamin C Liquid Supplement, 2.04 fl oz (60 mL) bottle, Manufactured By: Zaphiredelcor Cia, LTDA. Pasaje Luis Tola 9A Y Calle Juan Campuzano, Sector Carcelen, Quito-Ecuador 170302 Distributed By: Fitoterapia USA Inc., 500 NW 141 Ave. 112 Pembroke Pines, FL 33028