Drug Enforcement D-0323-2024

Labeling: Label Mix-up

Status

Terminated

Classification

Class I

Report Date

February 7, 2024

Termination Date

September 18, 2024

Product Information

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
Product quantity
4,662 bottles
Reason for recall
Labeling: Label Mix-up
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
USA nationwide

Location & Firm

Recalling firm
Azurity Pharmaceuticals, Inc.
Address
841 Woburn St

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0323-2024
Event ID
93786
Recall initiation date
January 4, 2024
Center classification date
February 12, 2024
Code info
Lot # F230169A, Exp. 06/30/2025
More code info
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