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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 90720

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

Open FDA event record

Event summary

Timeline bucket
August 08, 2022
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

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

Timolol Maleate Ophthalmic Solution, USP, 0.5%, 5 x 0.3 mL Single-Dose Vials, Rx Only, Sterile, Manufactured for: Akorn, Inc., Lake Forest, IL 60045. NDC 17478-189-24

D-1471-2022
Recall number
D-1471-2022
Initiated
August 08, 2022
Classification
Class III
Status
Ongoing
Recalling firm
Akorn, Inc
Quantity
5,226 Cartons (60 vials/carton)

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Failed Impurities/Degradation Specifications

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Impurities/Degradation Specifications: Identification of an unknown impurity at the 12-month stability point.

Code information

Lot #: 9N72, EXP 09/30/2022

Distribution pattern

Distributed Nationwide in the USA