Drug 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
D-0367-2022
Product summary
- Firm
- Akorn, Inc.
- Event
- Event 89142
- Status
- Terminated
- Classification
- Class III
- Quantity
- 10,836 bottles
- Official record key
drug-enforcement:D-0367-2022
Official wording
Reason: Labeling: Missing Label
Code information: Lot: 375153 Exp. 10/31/2022
Distribution pattern: Nationwide USA
Derived failure modes
-
Labeling or packaging
Labeling: Missing