# FDA recall D-0320-2020

> **FITOTERAPIA USA, INC** · Class I · drug recall initiated 2019-09-16.

## 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

- **Recall number:** D-0320-2020
- **Recalling firm:** FITOTERAPIA USA, INC
- **Classification:** Class I
- **Product type:** drug
- **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

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

## Citation

> AI Analytics. FDA recall D-0320-2020. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/D-0320-2020. Source: US FDA. Licensed CC0.

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