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D-0323-2024Class I

Azurity Pharmaceuticals, Inc.

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Azurity Pharmaceuticals, Inc.
Product type
Drug
Status
Terminated
Report date
2024-02-07
Distribution
USA nationwide
Firm state
MA
Product quantity
4,662 bottles
Initiated by
Voluntary: Firm initiated
Reason for recall

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

Code / lot info

Lot # F230169A, Exp. 06/30/2025

Other recalls SPEQ maps to Documentation & Change Control
See all Documentation & Change Control recalls →

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →