Home / Recalls / Akorn, Inc / D-1361-2022

D-1361-2022 Class II Ongoing

Recalled by Akorn, Inc — Gurnee, IL

FDA drug recall D-1361-2022 was initiated by Akorn, Inc on Aug 1, 2022 and is designated Class II. Reason for recall: Defective Container: Product has incomplete induction seals. The recall status is ongoing. Affected quantity: 14,712 bottles.

Recall Details

Product Type: Drugs
Report Date: Aug 24, 2022
Initiation Date: Aug 1, 2022
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 14,712 bottles

Product Description

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

Reason for Recall

Defective Container: Product has incomplete induction seals.

Distribution Pattern

Nationwide USA

Code Information

Lot# 379804, Exp. 8/31/2023

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-1361-2022
openFDA file date: Oct 23, 2026
Loaded by RegDataLab: Oct 25, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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