Exact FDA event identifier

Event 81436

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

Event summary

Timeline bucket: October 15, 2018
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Zero Xtreme USA

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

Zero Xtreme Dietary Supplement 30-count capsules. By:Zero Xtreme Registro Sanitario No SD2014-0002208 LLC-USA

D-0246-2019

Recall number: D-0246-2019
Initiated: October 15, 2018
Classification: Class II
Status: Terminated
Recalling firm: Zero Xtreme USA
Quantity: 16 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Marketed Without an Approved NDA/ANDA: Undeclared Sibutramine

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Marketed Without an Approved NDA/ANDA: Undeclared Sibutramine

Code information

Lot: 1220062085 Exp. 03/2020

Distribution pattern

Nationwide within the USA.