FDA Recall D-0323-2024
Azurity Pharmaceuticals, Inc. · Wilmington, MA
Class I — life-threatening Terminated 258 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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
Recall record
- Recall number
D-0323-2024- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- USA nationwide
- Recall initiated
- 2024-01-04
- Classified by FDA Center
- 2024-02-12
- FDA published
- 2024-02-07
- Terminated
- 2024-09-18
- Recalling firm
- Azurity Pharmaceuticals, Inc.
- Firm location
- Wilmington, MA
Drug identification
- Brand name(s)
- ZENZEDI
- Generic name(s)
- DEXTROAMPHETAMINE SULFATE
- Manufacturer(s)
- Azurity Pharmaceuticals, Inc.
- NDC(s)
24338-850, 24338-851, 24338-852, 24338-853, 24338-854, 24338-855, 24338-856- Route(s)
- ORAL