March 2019 FDA Recall Drug by Akorn Inc
D-1011-2019 - Sub Potent Drug

This Class II drug recall was voluntarily initiated by Akorn Inc on March 12, 2019 for the product Drug. The FDA reported the reason for recall as sub potent drug. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1011-2019

Reason for Recall
Sub Potent Drug: OOS results observed for the Hydrocortisone assay during routine stability testing at 12 month controlled room temperature.
Initiated
03-12-2019
Reported
03-27-2019
Quantity
15,322 10 ml bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
82375
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 and Puerto Rico
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-01-2022
Product Description About Product Description
Full technical description of the product.
Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL per dropper bottle, Rx only, Hi-Tech Pharmacal Co, Inc., Amityville, NY 11701. NDC: 50383-901-10

Batch or Lot Expiration Information

Lot# Lot: 357647, EXP 04/2019