Exact FDA event identifier

Event 89142

2 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: December 03, 2021
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

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

2 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 2

Morphine Sulfate Oral Solution 100 mg per 5 mL (20 mg/mL) 30 mL bottles, Rx only, Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701 -- NDC 50383-965-30

D-0367-2022

Recall number: D-0367-2022
Initiated: December 03, 2021
Classification: Class III
Status: Terminated
Recalling firm: Akorn, Inc.
Quantity: 10,836 bottles

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

Labeling: Missing

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling: Missing Label

Code information

Lot: 375153 Exp. 10/31/2022

Distribution pattern

Nationwide USA

drug · product 2 of 2

Oxycodone Hydrochloride Oral Solution, USP 5 mg per 5 mL (1 mg/mL), 500 mL bottle, Rx only, Manufactured by: Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701 --- NDC 50383-961-34

D-0368-2022

Recall number: D-0368-2022
Initiated: December 03, 2021
Classification: Class III
Status: Terminated
Recalling firm: Akorn, Inc.
Quantity: 8184 bottles

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

Labeling: Missing

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling: Missing Label

Code information

Lots: 377186 Exp. 2/28/2023; 377188 Exp. 3/31/2023

Distribution pattern

Nationwide USA