FDA recall D-0301-2021

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

Distribution

Nationwide USA

Key facts

Status

Terminated

Initiation date

2021-03-08

Report date

2021-03-24

Termination date

2022-08-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0301-2021