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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 86324

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

Open FDA event record

Event summary

Timeline bucket
July 02, 2020
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Edge Pharma, 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

Vancomycin HCL 1.5 mg Edge Pharma, LLC 856 Hercules Dr. Colchester, VT 05446 NDC 05446-1458-01

D-1562-2020
Recall number
D-1562-2020
Initiated
July 02, 2020
Classification
Class II
Status
Terminated
Recalling firm
Edge Pharma, LLC
Quantity
5 IV bags

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
Labeling: Label Error

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling: Label Error on Declared Strength

Code information

Lot # 06-2020-04@2 BUD 09-16-2020

Distribution pattern

WI