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

FDA recall notice · announced March 24, 2021 · Akorn

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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

Notes

Distribution: Nationwide USA
Lot/code information: Lot 369409, Exp. Date 05/2021; Lot 372393, Exp. Date 01/2022; Lot 373112, Exp. Date 04/2022
Quantity: 8,183 unit dose cups
Status: Terminated
Products in this recall event:
- 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- (D-0301-2021)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.