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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 90828

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
September 09, 2022
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Justified Laboratories

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

Complete imported group

Every recalled product in this event

2 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 2

Skincell Mole & Skin Corrector Serum, 1 fl. oz./30 mL jars, Distributed By: Justified Laboratoires, Arlington, TX 76011 USA UPC 8 10077 53220 1

D-0008-2023
Recall number
D-0008-2023
Initiated
September 09, 2022
Classification
Class II
Status
Terminated
Recalling firm
Justified Laboratories
Quantity
Unknown

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Marketed Without An Approved NDA/ANDA; Unapproved new drug

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Marketed Without An Approved NDA/ANDA; Unapproved new drug

Code information

All lots remaining within expiry.

Distribution pattern

United States including Puerto Rico and Canada

drug · product 2 of 2

Skincell Mole & Skin Corrector Serum, 1 fl. oz./30 mL jars, Distributed By: Justified Laboratoires, Arlington, TX 76011 USA UPC 8 10077 53221 8

D-0009-2023
Recall number
D-0009-2023
Initiated
September 09, 2022
Classification
Class II
Status
Terminated
Recalling firm
Justified Laboratories
Quantity
Unknown

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Marketed Without An Approved NDA/ANDA; Unapproved new drug

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Marketed Without An Approved NDA/ANDA; Unapproved new drug

Code information

All lots remaining within expiry.

Distribution pattern

United States including Puerto Rico and Canada