Why it was recalled
Labeling: Label Mix-up
Product description
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
Lot numbers, UPCs & expiration codes
Lot # F230169A, Exp. 06/30/2025
Where it was sold
USA nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0323-2024
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Jan 4, 2024
- FDA report date
- Feb 7, 2024
- Quantity
- 4,662 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Azurity Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-0323-2024, exactly as published.
Show all FDA fields
- City
- Wilmington
- State
- MA
- Status
- Terminated
- Country
- United States
- Event ID
- 93786
- Address
- 841 Woburn St
- Code information
- Lot # F230169A, Exp. 06/30/2025
- Postal code
- 01887-3414
- Report date
- Feb 7, 2024
- Product type
- Drugs
- Recall number
- D-0323-2024
- Classification
- Class I
- Recalling firm
- Azurity Pharmaceuticals, Inc.
- Product quantity
- 4,662 bottles
- Termination date
- Sep 18, 2024
- Reason for recall
- Labeling: Label Mix-up
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- USA nationwide
- Recall initiation date
- Jan 4, 2024
- Initial firm notification
- Letter
- Center classification date
- Feb 12, 2024