April 2017 FDA Recall Drug by Akorn, Inc.
D-0697-2017 - Product is being recalled due to low pH value.

This Class III drug recall was voluntarily initiated by Akorn, Inc. on April 20, 2017 for the product Drug. The FDA reported the reason for recall as product is being recalled due to low ph value.. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0697-2017

Reason for Recall
Product is being recalled due to low pH value.
Initiated
04-20-2017
Reported
05-17-2017
Quantity
1,292 kits

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
77071
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
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
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-21-2019
Product Description About Product Description
Full technical description of the product.
IC-Green (indocyanine green for injection, USP), 25 mg, packaged in a kit containing six vials of 25 mg lyophilized powder, Rx only, Manufactured by: Akorn, Inc., NDC 17478-701-02

Batch or Lot Expiration Information

Lot# Kit
Lot# 031126; Exp 8/2018