Gabapentin Oral Solution recalled over manufacturing violations

Recall date

December 15, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Akorn Inc recalls Gabapentin Oral Solution, 250 mg/5 mL (50 mg/mL) in a 470 mL amber-colored bottle, Rx Only. Manufactured by: Hi-Tech Ph…

Recall number

D-0211-2018

FDA classification

Class III

Brand / firm

Akorn Inc

Sold / distributed

Nationwide

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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