FDA recall D-0320-2020

Product

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

Reason for recall

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

Distribution

FL, PA, NY and Canada

Key facts

Status

Terminated

Initiation date

2019-09-16

Report date

2019-11-06

Termination date

2021-10-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

Pembroke Pines, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0320-2020