Exact FDA event identifier

Event 80359

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

Event summary

Timeline bucket: June 22, 2018
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Eb5 Corporation

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

eb5 Skincare that Works. Age Spot Treatment. Skin Lightening Cream with 2% Hydroquinone. 177.4 ml / 6 fl oz carton containing a tube. Manufactured For: EB5 Corporation Portland, OR 97210 Carton Bar Code: 7 41099 00009 9

D-0908-2018

Recall number: D-0908-2018
Initiated: June 22, 2018
Classification: Class II
Status: Terminated
Recalling firm: Eb5 Corporation
Quantity: 4,632 tubes

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

Out-of-specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Stability Specifications: Out-of-specification for viscosity, pH and specific gravity

Code information

Batch B4276A EXP 03/2019

Distribution pattern

Distributed Nation Wide in the USA.