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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83843

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

Open FDA event record

Event summary

Timeline bucket
September 20, 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

Phenylephrine Hydrochloride Ophthalmic Solution, USP, 2.5%, 15 mL bottle, Rx only, Mfd. by: Akorn, Inc., Lake Forest, IL 60045; NDC 17478-201-15.

D-1883-2019
Recall number
D-1883-2019
Initiated
September 20, 2019
Classification
Class II
Status
Terminated
Recalling firm
Akorn, Inc.
Quantity
60,176 bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Out of specification
Sterility assurance reason.sterility_assurance · v1.0.0
Lack of Assurance of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Assurance of Sterility: Out of specification results for container closure test which cannot guarantee the sterility of the product.

Code information

Lot #: 031908A, Exp 03/20

Distribution pattern

Nationwide in the USA and Puerto Rico