Akorn, Inc.: Drug Recall
Recall #D-0368-2022 · 12/03/2021
Class III: Low Risk
Recall Details
- Recall Number
- D-0368-2022
- 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
- 8184 bottles
Reason for Recall
Labeling: Missing Label
Product Description
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
Distribution Pattern
Nationwide USA
Other Recalls by Akorn, Inc.
- Class II: Risk 04/26/2023
- Class II: Risk 04/26/2023
- Class II: Risk 04/26/2023
- Class II: Risk 04/26/2023
- Class II: Risk 04/26/2023
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.