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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 88005

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

Open FDA event record

Event summary

Timeline bucket
May 14, 2021
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Medline Industries Inc

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

READYPREP CHG, 2% Chlorhexidine Gluconate Cloth, 2 9x10.5 in (22.9x26.7 cm) Disposable Cloths, Non-Sterile, Single Use Only, Manufactured by Medline Industries, Inc., Northfield, IL 60093 USA. NDC: 53329-244-01

D-0624-2021
Recall number
D-0624-2021
Initiated
May 14, 2021
Classification
Class III
Status
Terminated
Recalling firm
Medline Industries Inc
Quantity
231,936 packs

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Superpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Superpotent Drug: Product is above specification for active ingredient, 2% Chlorhexidine Gluconate.

Code information

Lot #:: 19EEA027, Exp May 2021; 19GEA049, Exp August 2021; 19HEA044, Exp Sept 2021

Distribution pattern

Distributed Nationwide in the USA and Isreal