Exact FDA event identifier

Event 81193

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

Event summary

Timeline bucket: October 08, 2018
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

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

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

Gentamicin Sulfate Ophthalmic Solution, USP 0.3%, 5 mL dropper bottle, Rx Only, Manufactured by: Akorn, Inc. Lake Forest, IL 60045, NDC 17478-283-10

D-0414-2019

Recall number: D-0414-2019
Initiated: October 08, 2018
Classification: Class II
Status: Terminated
Recalling firm: Akorn, Inc.
Quantity: 149,159 5mL bottles

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0

Particulate Matter

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Presence of Particulate Matter: Crystalline particles were noticed at the 24 month clarity testing.

Code information

Lots: 6C02A Exp. 02/19; 5K42A Exp. 09/2018; 7D47A Exp. 03/2020

Distribution pattern

Nationwide USA and Puerto Rico