DEXTROAMPHETAMINE SULFATE Recall D-0323-2024
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
DEXTROAMPHETAMINE SULFATE Recall D-0323-2024 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0323-2024 |
| Event ID | 93786 |
| Brand | ZENZEDI |
| Generic Name | DEXTROAMPHETAMINE SULFATE |
| Manufacturer | DEXTROAMPHETAMINE SULFATE |
| Original Package? | 1 |
| Active Substance | DEXTROAMPHETAMINE SULFATE |
| Drug Route | ORAL |
| Distribution | USA nationwide |
| Quantity | 4,662 bottles |
| Recall Reason | Labeling: Label Mix-up |
| Drug Classification | Class I |
| Drug Code Info | 20240207 |
| Product NDC | 24338-850 24338-851 24338-852 |
| Drug UPC | 0324338854037 0324338852033 0324338850039 |
| Recall Initiation Date | 20240104 |
| Report Date | 20240207 |
| Classification Date | 20240212 |
| Address | 841 Woburn St Wilmington, MA 01887-3414 United States |
| Recalling Firm | Azurity Pharmaceuticals, Inc. |
| Initial Notification | Letter |
| Unique Ingredient Identifier | JJ768O327N |
| Drug Application Number | ANDA090533 |
| Structured Product Labeling (SPL ID) | ca930673-eecb-4c89-821f-c0dbd4b208b2 |
| Structured Product Labeling (SPL Set ID) | d6394df5-f2c9-47eb-b57e-f3e9cfd94f84 |
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