Gabapentin Oral Solution, 250 mg/5 mL (50 mg/mL) in a 470 mL amber-colored bottle, Rx Only. Manu...
FDA Recall #D-0211-2018 — Class III — December 15, 2017
Product Description
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
Reason for Recall
CGMP Deviations: Inadvertent release of a drug product with unapproved active ingredient manufacturer.
Recalling Firm
Akorn Inc — Lake Forest, IL
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
4,885 bottles
Distribution
Nationwide
Code Information
Batch# 359774; Exp. 09/02/19
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated