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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83721

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

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Event summary

Timeline bucket
September 17, 2019
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Akorn, 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

Lidocaine Hydroclhoride Jelly USP, 2%, 30 mL tubes, Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-711-30

D-1878-2019
Recall number
D-1878-2019
Initiated
September 17, 2019
Classification
Class II
Status
Terminated
Recalling firm
Akorn, Inc.
Quantity
10,543 tubes

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0
particulate matter
Manufacturing or process control reason.manufacturing_process_control · v1.0.0
cGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

cGMP Deviations: firm reported finding metal particulate matter in the filling room near the tube feeder during the filling operation of the product. No particulates were identified in the product, but rather were identified on the filling line.

Code information

Lot #: 9B21A, Exp. 1/2022

Distribution pattern

Nationwide within the United States and Puerto Rico