Drug 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
D-0320-2020
Product summary
- Event
- Event 83812
- Status
- Terminated
- Classification
- Class I
- Quantity
- 9000 bottles
- Official record key
drug-enforcement:D-0320-2020
Official wording
Reason: Marketed without an approved NDA/ANDA: Product found to be tainted with Tadalafil.
Code information: Lot #: ZD-078-19 Exp. 27-04-2020
Distribution pattern: FL, PA, NY and Canada
Derived failure modes
-
Unknown
Marketed without an approved NDA/ANDA: Product found to be tainted with Tadalafil.