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.
The agency’s classification
FDA (Drugs): Class I
Class I is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. 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…
- 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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