August 2014 FDA Recall Drug by Akorn, Inc.
D-1571-2014 - Failed Impurity/Degradation Specification; high out of specification result for 23 transacetyl impurity at the 22 month stability time point

This Class III drug recall was voluntarily initiated by Akorn, Inc. on August 5, 2014 for the product Drug. The FDA reported the reason for recall as failed impurity/degradation specification; high out of specification result for 23 transacetyl impurity at the 22 month stability time point. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1571-2014

Reason for Recall
Failed Impurity/Degradation Specification; high out of specification result for 23 transacetyl impurity at the 22 month stability time point
Initiated
08-05-2014
Reported
10-01-2014
Quantity
5,539 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
69013
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.
05-21-2015
Product Description About Product Description
Full technical description of the product.
Rifampin for Injection USP, 600 mg*/vial (Sterile), supplied in sterile glass vials, Rx only For IV Infusion only, individually boxed, Mfd. for: Akorn, Inc., Lake Forest, IL --- NDC 17478-151-42

Batch or Lot Expiration Information

Lot# Lot: 12RIF4A, Expiration Date: 9/30/2014