Zenzedi Tablet
FDA Recall NDC 24338-855
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Zenzedi (NDC 24338-855). A significant event, classified as Class I, was initiated on Jan 04, 2024 by Azurity Pharmaceuticals, Inc.. The reported reason for this action was: "Labeling: Label Mix-up"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class I Terminated
Labeling: Label Mix-up
Jan 04, 2024
Feb 07, 2024
4,662 bottles
Recall Profile & Regulatory Data
Event ID
93786
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Azurity Pharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA nationwide
Termination Date
Sep 18, 2024
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
Batch or Lot Expiration Information
Lot# F230169A, Exp. 06/30/2025
Affected Packages Involved in this Recall
24338-850-03Product
24338-851-03Product
24338-852-03Product
24338-853-03Product
24338-854-03Product
24338-855-03Product
24338-856-03Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
