Why it was recalled
Marketed without an approved NDA/ANDA: Product found to be tainted with Tadalafil.
Product description
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
Lot numbers, UPCs & expiration codes
Lot #: ZD-078-19 Exp. 27-04-2020
Where it was sold
FL, PA, NY and Canada
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0320-2020
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Sep 16, 2019
- FDA report date
- Nov 6, 2019
- Quantity
- 9000 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- FITOTERAPIA USA, INC
Original FDA data
Every field from FDA enforcement report D-0320-2020, exactly as published.
Show all FDA fields
- City
- Pembroke Pines
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 83812
- Address
- 500 NW 141st Ave
- Code information
- Lot #: ZD-078-19 Exp. 27-04-2020
- Postal code
- 33028-2310
- Report date
- Nov 6, 2019
- Product type
- Drugs
- Recall number
- D-0320-2020
- Classification
- Class I
- Recalling firm
- FITOTERAPIA USA, INC
- Product quantity
- 9000 bottles
- Termination date
- Oct 27, 2021
- Reason for recall
- Marketed without an approved NDA/ANDA: Product found to be tainted with Tadalafil.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- FL, PA, NY and Canada
- Recall initiation date
- Sep 16, 2019
- Initial firm notification
- Press Release
- Center classification date
- Nov 12, 2019