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 for recall: Failed Impurities/Degradation Specifications; out of specification for unknown impurity observed during 6 month stability testing
Recall initiated: 20210308
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated