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

Recall Number: D-0301-2021

Firm: Akorn, Inc.

Classification: Class II

Status: Terminated

Report Date: 20210324

Initiation Date: 20210308

Termination Date: 20220809

Failed Impurities/Degradation Specifications; out of specification for unknown impurity observed during 6 month stability testing

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