Exact FDA event identifier

Event 83812

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket: September 16, 2019
Product types: Drug
Classifications: Class I
Statuses: Terminated
Recalling firm wording: FITOTERAPIA USA, INC

Dossier provenance

Source snapshots represented here

openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 1

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

Recall number: D-0320-2020
Initiated: September 16, 2019
Classification: Class I
Status: Terminated
Recalling firm: FITOTERAPIA USA, INC
Quantity: 9000 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Marketed without an approved NDA/ANDA: Product found to be tainted with Tadalafil.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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