Azurity Pharmaceuticals, Inc.: Drug Recall

Recall #D-0323-2024 · 01/04/2024

Class I: Dangerous

Recall Details

Recall Number: D-0323-2024
Classification: Class I
Product Type: Drug
Recalling Firm: Azurity Pharmaceuticals, Inc.
Status: Terminated
Date Initiated: 01/04/2024
Location: Wilmington, MA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 4,662 bottles

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

Distribution Pattern

USA nationwide

Other Recalls by Azurity Pharmaceuticals, Inc.

Class III: Low Risk 12/08/2023

Failed Impurities/Degradation Specifications: Out of specification Impurity C (4,5-desisopropylidene topiramate) result observed during routine stability testing at 18 months.
Class II: Risk 02/15/2023

cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.
Class I: Dangerous 08/24/2021

Product Mix-up: Incorrect diluent component included in the kit.

View all recalls by Azurity Pharmaceuticals, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.