Exact FDA event identifier

Event 90676

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

Event summary

Timeline bucket: August 01, 2022
Product types: Drug
Classifications: Class II
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

PrednisoLONE Oral Solution USP, 15 mg per 5 mL, 240 ml bottle, Rx Only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701. NDC: 50383-042-24

D-1361-2022

Recall number: D-1361-2022
Initiated: August 01, 2022
Classification: Class II
Status: Ongoing
Recalling firm: Akorn, Inc
Quantity: 14,712 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Defective Container: Product has incomplete induction seals.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Defective Container: Product has incomplete induction seals.

Code information

Lot# 379804, Exp. 8/31/2023

Distribution pattern

Nationwide USA