Drug 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
D-0368-2022
Product summary
- Firm
- Akorn, Inc.
- Event
- Event 89142
- Status
- Terminated
- Classification
- Class III
- Quantity
- 8184 bottles
- Official record key
drug-enforcement:D-0368-2022
Official wording
Reason: Labeling: Missing Label
Code information: Lots: 377186 Exp. 2/28/2023; 377188 Exp. 3/31/2023
Distribution pattern: Nationwide USA
Derived failure modes
-
Labeling or packaging
Labeling: Missing