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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 86390

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

Open FDA event record

Event summary

Timeline bucket
September 03, 2020
Product types
Drug
Classifications
Class I
Statuses
Terminated
Recalling firm wording
CORGIOMED LLC

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

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

Leafree Instant Hand Sanitizer Aloe Vera (ethyl alcohol 70% v/v), Kills 99.99% Germs, EDIBLE ALCOHOL, a) 100 mL bottles, UPC code 6970495860325, b) 300 mL bottles, UPC code 6970495860318, and c) 500 mL bottles, UPC code 6970495860301, Exclusively Distributed by: Corgiomed LLC, McLean, VA 22102, USA, Made in China.

D-1586-2020
Recall number
D-1586-2020
Initiated
September 03, 2020
Classification
Class I
Status
Terminated
Recalling firm
CORGIOMED LLC
Quantity
28900 bottles

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
misbranded

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Marketed without an Approved NDA/ANDA; product labeled as Edible Alcohol rendering the product an unapproved new drug and misbranded.

Code information

Lot # 2020A3010, Exp 05/30/2022

Distribution pattern

NC and MD