FDA Drug recall D-1340-2020
Prednisolone Sodium Phosphate Oral Solution, 5 mg/5 mL, 120 mL Bottle, Rx only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701
- FDA Drug
- Class III
- terminated
- Published 2020-06-17
On 2020-06-17 the FDA classified a Class III recall of Prednisolone Sodium Phosphate Oral Solution, 5 mg/5 mL, 120 mL Bottle, Rx only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701 by Akorn, citing discoloration: Out of Specification (OOS) result for APHA Color Test.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1340-2020 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2020-06-05 |
| Published | 2020-06-17 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Akorn |
| Distribution | US |
Product
Prednisolone Sodium Phosphate Oral Solution, 5 mg/5 mL, 120 mL Bottle, Rx only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701. NDC: 50383-040-04
Reason
Discoloration: Out of Specification (OOS) result for APHA Color Test.
Identifiers
| code_info | Lot# 365566, 365568 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1340-2020%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.