PlainRecordsFDA · Drug recall
Mero Macho Artificially Flavored Passion Fruit Vitamin C Liquid Supplement…
- Date
- Nov. 6, 2019
- Risk class
- Class I (FDA's definition, 21 CFR 7.3(m): 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)
- Status
- Terminated
- Filed by
- Fitoterapia USA, Inc
- 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
- Marketed without an approved NDA/ANDA: Product found to be tainted with Tadalafil.
- Distribution pattern
- FL, PA, NY and Canada
- Quantity
- 9000 bottles
- Codes and lots
- Lot #: ZD-078-19 Exp. 27-04-2020
- Recall started
- Sept. 16, 2019
- Recall number
- D-0320-2020
What should I do? Medicine recall: what to do
Source: FDA · Drug enforcement report, recall number D-0320-2020. The agency record governs; check it and the company before acting.