March 2021 FDA Recall Drug by Akorn, Inc.
D-0301-2021 - Failed Impurities/Degradation Specifications; out of specification for unknown impurity observed during 6 month stability testing

This Class II drug recall was voluntarily initiated by Akorn, Inc. on March 8, 2021 for the product Drug. The FDA reported the reason for recall as failed impurities/degradation specifications; out of specification for unknown impurity observed during 6 month stability testing. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0301-2021

Reason for Recall
Failed Impurities/Degradation Specifications; out of specification for unknown impurity observed during 6 month stability testing
Initiated
03-08-2021
Reported
03-24-2021
Quantity
8,183 unit dose cups

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87462
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Akorn, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-09-2022
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# Lot 369409, Exp. Date 05/2021; Lot 372393, Exp. Date 01/2022; Lot 373112, Exp. Date 04/2022