August 2015 FDA Recall Drug by Akorn, Inc.
D-0295-2016 - Defective Container

This Class III drug recall was voluntarily initiated by Akorn, Inc. on August 21, 2015 for the product Drug. The FDA reported the reason for recall as defective container. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0295-2016

Reason for Recall
Defective Container: Product missing safety seal around the neck of the bottle. The product label indicates, "Tamper Evident: Do not use if printed seal around cap is broken or missing." Because the product is missing the approved component and is not consistent with the labeling, the lot is being recalled.
Initiated
08-21-2015
Reported
11-25-2015
Quantity
13,896 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
72351
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 and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
11-29-2017
Product Description About Product Description
Full technical description of the product.
Hydrocortisone and Acetic Acid Otic Solution, USP, containing hydrocortisone (1%) and acetic acid (2%), 10 mL bottles, Rx Only, Hi-Tech Pharmacal, Amityville, NY 11701, Made in USA, NDC # 50383-901-10

Batch or Lot Expiration Information

Lot# 346191, Exp. 12/2016