Mero Macho Liquid Supplement Recalled for Tadalafil Contamination
Fitoterapia USA Inc. is recalling Mero Macho Passion Fruit Vitamin C Liquid Supplement because it was marketed without an approved NDA/ANDA and found to be tainted with Tadalafil.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which corresponds to a Critical severity score of 5 according to the rubric.
Plain-English summary
Fitoterapia USA Inc. is recalling 9,000 bottles of Mero Macho Artificially Flavored Passion Fruit Vitamin C Liquid Supplement, 2.04 fl oz (60 mL). The product was manufactured by Zaphiredelcor Cia, LTDA. in Ecuador and distributed by Fitoterapia USA Inc. in Pembroke Pines, Florida.
The recall was initiated because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA) and was found to be tainted with Tadalafil. The affected lot number is ZD-078-19 with an expiration date of 27-04-2020.
The product was distributed in Florida, Pennsylvania, New York, and Canada. Consumers who have this product should stop using it and contact the recalling firm for further instructions.
The recalled product
- 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.
- Manufacturer
- FITOTERAPIA USA, INC
- Category
- Drug — Liquid Supplement
- Affected units
- 9,000
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot #: ZD-078-19 Exp. 27-04-2020
Distribution
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