FDA recall D-0367-2022
Akorn, Inc. · Class III · 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
Reason for recall
Labeling: Missing Label
Distribution
Nationwide USA
Key facts
- Status
- Terminated
- Initiation date
- 2021-12-03
- Report date
- 2022-01-19
- Termination date
- 2022-08-19
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Lake Forest, IL, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0367-2022