Recalls / Class I
Class ID-0323-2024
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences 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
- Brand name
- Zenzedi
- Generic name
- Dextroamphetamine Sulfate
- Active ingredient
- Dextroamphetamine Sulfate
- Route
- Oral
- NDCs
- 24338-850, 24338-851, 24338-852, 24338-853, 24338-854, 24338-855, 24338-856
- FDA application
- ANDA090533
- Affected lot / code info
- Lot # F230169A, Exp. 06/30/2025
Why it was recalled
Labeling: Label Mix-up
Recalling firm
- Firm
- Azurity Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 841 Woburn St, Wilmington, Massachusetts 01887-3414
Distribution
- Quantity
- 4,662 bottles
- Distribution pattern
- USA nationwide
Timeline
- Recall initiated
- 2024-01-04
- FDA classified
- 2024-02-12
- Posted by FDA
- 2024-02-07
- Terminated
- 2024-09-18
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0323-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.