FDA Drug recall D-0301-2021
Gabapentin Oral Solution, 250 mg/5 mL, 5 mL per unit dose cup, four unit dose cups per tray, For Institutional Use Only, Rx only, Hi-Tech P…
- FDA Drug
- Class II
- terminated
- Published 2021-03-24
On 2021-03-24 the FDA classified a Class II recall of Gabapentin Oral Solution, 250 mg/5 mL, 5 mL per unit dose cup, four unit dose cups per tray, For Institutional Use Only, Rx only, Hi-Tech P… by Akorn, citing failed Impurities/Degradation Specifications; out of specification for unknown impurity observed during 6 month stability testing.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0301-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-03-08 |
| Published | 2021-03-24 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Akorn |
| Distribution | US |
Product
Gabapentin Oral Solution, 250 mg/5 mL, 5 mL per unit dose cup, four unit dose cups per tray, For Institutional Use Only, Rx only, Hi-Tech Pharmacal Co., Inc, Amityville, NY 11701, NDC Tray: 50383-311-07; NDC Unit Dose Cup 50383-311-07
Reason
Failed Impurities/Degradation Specifications; out of specification for unknown impurity observed during 6 month stability testing
Identifiers
| code_info | Lot 369409, Exp. Date 05/2021; Lot 372393, Exp. Date 01/2022; Lot 373112, Exp. Date 04/2022 |
|---|
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-0301-2021%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.