Exact FDA event identifier

Event 84913

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

Event summary

Timeline bucket: December 16, 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

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

Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL dropper bottle, Rx only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701; NDC 50383-901-10.

D-0839-2020

Recall number: D-0839-2020
Initiated: December 16, 2019
Classification: Class II
Status: Terminated
Recalling firm: Akorn Inc
Quantity: 16,078 bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

Subpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Subpotent Drug: Low Out of specification (OOS) assay results for the hydrocortisone portion of this product.

Code information

Lot #: 364667, Exp 12/20/2019

Distribution pattern

Nationwide in the USA and Puerto Rico