D-0320-2020 Class I Terminated

Recalled by FITOTERAPIA USA, INC — Pembroke Pines, FL

Recall Details

Product Type
Drugs
Report Date
November 6, 2019
Initiation Date
September 16, 2019
Termination Date
October 27, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
9000 bottles

Product Description

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 Pattern

FL, PA, NY and Canada

Code Information

Lot #: ZD-078-19 Exp. 27-04-2020