PlainRecalls
FDA Drug Critical Class I Terminated

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

Reported: February 7, 2024 Initiated: January 4, 2024 #D-0323-2024

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

Reason for Recall

Labeling: Label Mix-up

Details

Units Affected
4,662 bottles
Distribution
USA nationwide
Location
Wilmington, MA

Frequently Asked Questions

What product was recalled?
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. Recalled by Azurity Pharmaceuticals, Inc.. Units affected: 4,662 bottles.
Why was this product recalled?
Labeling: Label Mix-up
Which agency issued this recall?
This recall was issued by the FDA Drug on February 7, 2024. Severity: Critical. Recall number: D-0323-2024.