Akorn, Inc. recalls Gabapentin Oral Solution, 250 mg/5 mL, 5 mL per unit dose cup, four unit dose cups per tray, For Institutional Use Only,
Recalled March 24, 2021 · FDA recall D-0301-2021 · Akorn
Hazard
Failed Impurities/Degradation Specifications; out of specification for unknown impurity observed during 6 month stability testing · FDA Class II
Units
8,183 unit dose cups
Sold at
Nationwide USA
Description
Failed Impurities/Degradation Specifications; out of specification for unknown impurity observed during 6 month stability testing
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
Manufacturer(s)
Akorn, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →