Pembroke Pines, FL, United States
FITOTERAPIA USA, INC recalls
1 recall recorded since 2018, most recently on 16 September 2019. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)1
Terminated Class I Drugs
- Recall started
- 16 September 2019
- Terminated
- 27 October 2021
- Reason
- Marketed without an approved NDA/ANDA: Product found to be tainted with Tadalafil.
- Distribution
- FL, PA, NY and Canada
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0320-2020
- 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.