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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 93318

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

Open FDA event record

Event summary

Timeline bucket
October 17, 2023
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
EMD Millipore Corporation

Dossier provenance

Source snapshots represented here

  • openFDA Device 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.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

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.

device · product 1 of 1

Lugol s Iodine Solution 500ML, Part Number 624-71

Z-0408-2024
Recall number
Z-0408-2024
Initiated
October 17, 2023
Classification
Class II
Status
Ongoing
Recalling firm
EMD Millipore Corporation
Quantity
5 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
incorrect packaging

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to the incorrect packaging utilized with lot 3124, there' s an improper seal between the cap and bottle. With an improper seal the Assay (current specification of 24.8 to 27.2 mL) is expected to continue to drop over time as iodine vapors continue to dissipate from the bottles.

Code information

Lot Number 3124

Distribution pattern

US States: CA, NJ, WV