FDA recall D-0323-2024
Azurity Pharmaceuticals, Inc. · Class I · drug
Product
Zenzedi (Dextroamphetamine Sulfate) CII Tablets, USP, 30 mg, 30-count bottle, Rx only, Mfd. for: Arbor Pharmaceuticals, LLC., Atlanta, Georgia, 30328, NDC 24338-856-03
Reason for recall
Labeling: Label Mix-up
Distribution
USA nationwide
Key facts
- Status
- Terminated
- Initiation date
- 2024-01-04
- Report date
- 2024-02-07
- Termination date
- 2024-09-18
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Wilmington, MA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0323-2024