# FDA recall D-1361-2022

> **Akorn, Inc** · Class II · drug recall initiated 2022-08-01.

## Product

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

Nationwide USA

## Key facts

- **Recall number:** D-1361-2022
- **Recalling firm:** Akorn, Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2022-08-01
- **Report date:** 2022-08-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Gurnee, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1361-2022

## Citation

> AI Analytics. FDA recall D-1361-2022. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-1361-2022. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*