Exact FDA event identifier

Event 91580

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

Event summary

Timeline bucket: January 30, 2023
Product types: Drug
Classifications: Class III
Statuses: Ongoing
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

Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The Eye, 2 mL bottle, Sterile, Rx only, Distributed by: Akorn Operating Company LLC, Gurnee, IL 60031. NDC: 17478-215-02

D-0265-2023

Recall number: D-0265-2023
Initiated: January 30, 2023
Classification: Class III
Status: Ongoing
Recalling firm: Akorn, Inc.
Quantity: 45,117 Bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

Out of specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Stability Specifications: Out of specification test results for viscosity was identified at the 12M stability timepoint.

Code information

Lot: 081031A, Exp 2/28/2023

Distribution pattern

Nationwide in the USA and Puerto Rico