Exact FDA event identifier

Event 70661

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

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Event summary

Timeline bucket: March 10, 2015
Product types: Drug
Classifications: Class I
Statuses: Terminated
Recalling firm wording: Ultra ZX Supplements

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

ULTRA ZX DIETARY SUPPLEMENT (Extracto de Naranjo Amargo 70, Extracto de semilla de Sen 47.6, Lagrima de Coix 42, Almidon Medico 84), 30 capsule bottles, Manufactured and distributed by: Ultra ZX Labs, L.L.C. 2525 SW 3rd Ave Apt 1704 Miami, Florida 33129-2068.

D-0991-2015

Recall number: D-0991-2015
Initiated: March 10, 2015
Classification: Class I
Status: Terminated
Recalling firm: Ultra ZX Supplements
Quantity: 636 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Marketed Without An Approved NDA/ANDA: FDA laboratory analysis confirmed that ULTRA ZX contains undeclared sibutramine and phenolphthalein

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Marketed Without An Approved NDA/ANDA: FDA laboratory analysis confirmed that ULTRA ZX contains undeclared sibutramine and phenolphthalein

Code information

All lots/codes/bottles/packages.

Distribution pattern

Nationwide and Puerto Rico Foreign: Spain and Ecuador