September 2019 FDA Recall Drug by Fitoterapia Usa, Inc
D-0320-2020 - Marketed without an approved NDA/ANDA

This Class I drug recall was voluntarily initiated by Fitoterapia Usa, Inc on September 16, 2019 for the product Drug. The FDA reported the reason for recall as marketed without an approved nda/anda. The product was distributed in FL, PA, NY and Canada and the recall is currently terminated.

Recall Number: D-0320-2020

Reason for Recall
Marketed without an approved NDA/ANDA: Product found to be tainted with Tadalafil.
Initiated
09-16-2019
Reported
11-06-2019
Quantity
9000 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
83812
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
FITOTERAPIA USA, INC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
FL, PA, NY and Canada
Termination Date About Termination Date
Date that FDA officially terminated the recall.
10-27-2021
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

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