August 2022 FDA Recall Drug by Akorn, Inc
D-1361-2022 - Defective Container

This Class II drug recall was voluntarily initiated by Akorn, Inc on August 1, 2022 for the product Drug. The FDA reported the reason for recall as defective container. The product was distributed Nationwide and the recall is currently ongoing.

Recall Number: D-1361-2022

Reason for Recall
Defective Container: Product has incomplete induction seals.
Initiated
08-01-2022
Reported
08-24-2022
Quantity
14,712 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
90676
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.
Ongoing
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
Product Description About Product Description
Full technical description of the product.
PrednisoLONE Oral Solution USP, 15 mg per 5 mL, 240 ml bottle, Rx Only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701. NDC: 50383-042-24

Batch or Lot Expiration Information

Lot# 379804, Exp. 8/31/2023