Multi-event December 2021 FDA Recall Drug by Akorn, Inc.

This Multi-event Class III drug recall was voluntarily initiated by Akorn, Inc. on December 3, 2021 for the product Drug. The FDA reported the reason for recall as labeling. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-0368-2022 TERMINATED D-0367-2022 TERMINATED

Recall Number: D-0368-2022

Reason for Recall
Labeling: Missing Label
Initiated
12-03-2021
Reported
01-19-2022
Quantity
8184 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89142
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 USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-19-2022
Product Description About Product Description
Full technical description of the product.
Oxycodone Hydrochloride Oral Solution, USP 5 mg per 5 mL (1 mg/mL), 500 mL bottle, Rx only, Manufactured by: Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701 --- NDC 50383-961-34

Batch or Lot Expiration Information

Lot# Lots: 377186 Exp. 2/28/2023; 377188 Exp. 3/31/2023

Recall Number: D-0367-2022

Reason for Recall
Labeling: Missing Label
Initiated
12-03-2021
Reported
01-19-2022
Quantity
10,836 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
89142
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 USA
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-19-2022
Product Description About Product Description
Full technical description of the product.
Morphine Sulfate Oral Solution 100 mg per 5 mL (20 mg/mL) 30 mL bottles, Rx only, Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701 -- NDC 50383-965-30

Batch or Lot Expiration Information

Lot# Lot: 375153 Exp. 10/31/2022