FDA Drug recall D-1361-2022
PrednisoLONE Oral Solution USP, 15 mg per 5 mL, 240 ml bottle, Rx Only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701
- FDA Drug
- Class II
- ongoing
- Published 2022-08-24
On 2022-08-24 the FDA classified a Class II recall of PrednisoLONE Oral Solution USP, 15 mg per 5 mL, 240 ml bottle, Rx Only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701 by Akorn, citing defective Container: Product has incomplete induction seals.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1361-2022 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-08-01 |
| Published | 2022-08-24 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Akorn |
| Distribution | US |
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
Defective Container: Product has incomplete induction seals.
Identifiers
| code_info | Lot# 379804, Exp. 8/31/2023 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1361-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.