FDA Recall D-0320-2020
FITOTERAPIA USA, INC · Pembroke Pines, FL
Class I — life-threatening Terminated 772 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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.
Recall record
- Recall number
D-0320-2020- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- FL, PA, NY and Canada
- Recall initiated
- 2019-09-16
- Classified by FDA Center
- 2019-11-12
- FDA published
- 2019-11-06
- Terminated
- 2021-10-27
- Recalling firm
- FITOTERAPIA USA, INC
- Firm location
- Pembroke Pines, FL