PlainRecalls
FDA Drug Critical Class I Terminated

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

Reported: November 6, 2019 Initiated: September 16, 2019 #D-0320-2020

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.

Details

Recalling Firm
FITOTERAPIA USA, INC
Units Affected
9000 bottles
Distribution
FL, PA, NY and Canada
Location
Pembroke Pines, FL

Frequently Asked Questions

What product 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. Recalled by FITOTERAPIA USA, INC. Units affected: 9000 bottles.
Why was this product recalled?
Marketed without an approved NDA/ANDA: Product found to be tainted with Tadalafil.
Which agency issued this recall?
This recall was issued by the FDA Drug on November 6, 2019. Severity: Critical. Recall number: D-0320-2020.