Akorn, Inc.: Drug Recall

Recall #D-0367-2022 · 12/03/2021

Class III: Low Risk

Recall Details

Recall Number
D-0367-2022
Classification
Class III
Product Type
Drug
Recalling Firm
Akorn, Inc.
Status
Terminated
Date Initiated
12/03/2021
Location
Lake Forest, IL, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
10,836 bottles

Reason for Recall

Labeling: Missing Label

Product Description

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

Distribution Pattern

Nationwide USA

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.