Gabapentin Oral Solution, 250 mg/5 mL (50 mg/mL) in a 470 mL amber-colored bottle, Rx Only. Manufactured by: Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701. NDC: 50383-311-47

Recall Number: D-0211-2018

Firm: Akorn Inc

Classification: Class III

Status: Terminated

Report Date: 20180117

Initiation Date: 20171215

Termination Date: 20190410

CGMP Deviations: Inadvertent release of a drug product with unapproved active ingredient manufacturer.

Gabapentin Oral Solution, 250 mg/5 mL (50 mg/mL) in a 470 mL amber-colored bottle, Rx Only. Manufactured by: Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701. NDC: 50383-311-47