Exact FDA event identifier

Event 72227

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

Event summary

Timeline bucket: July 02, 2015
Product types: Drug
Classifications: Class I
Statuses: Ongoing
Recalling firm wording: XTREME Z DISTRIBUTORS 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

Zero Xtreme High Performance Fat Burner capsules, 30-count bottle, Distributed by Xtreme Z Distributors, Inc., Miami, FL 33180

D-1165-2016

Recall number: D-1165-2016
Initiated: July 02, 2015
Classification: Class I
Status: Ongoing
Recalling firm: XTREME Z DISTRIBUTORS INC
Quantity: 70,350 capsules

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Marketed Without an Approved NDA/ANDA: FDA sampling and analysis confirmed the presence of sibutramine and desmethylsibutramine.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Marketed Without an Approved NDA/ANDA: FDA sampling and analysis confirmed the presence of sibutramine and desmethylsibutramine.

Code information

Lot 1220062085, Exp. 09/16

Distribution pattern

Nationwide