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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 81836

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

Open FDA event record

Event summary

Timeline bucket
December 20, 2018
Product types
Drug
Classifications
Class III
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

COSOPT Ophthalmic Solution, USP, (2% Dorzolamide Hydrochloride, 0.5% Timolol Maleate), 10 mL dropper bottle, Sterile, Rx only, Distributed by: Akorn, Inc., Lake Forest, IL, NDC: 17478-605-10

D-0483-2019
Recall number
D-0483-2019
Initiated
December 20, 2018
Classification
Class III
Status
Terminated
Recalling firm
Akorn Inc
Quantity
30,794 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 results for opalescence at 7 month stability study.

Code information

Lots: 426007 and 426008, exp 4/2020

Distribution pattern

Nationwide USA and Puerto Rico