Azurity Pharmaceuticals, Inc.: Drug Recall

Recall #D-0213-2024 · 12/08/2023

Class III: Low Risk

Recall Details

Recall Number: D-0213-2024
Classification: Class III
Product Type: Drug
Recalling Firm: Azurity Pharmaceuticals, Inc.
Status: Terminated
Date Initiated: 12/08/2023
Location: Wilmington, MA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 2,220 bottles

Reason for Recall

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

Product Description

Eprontia (topiramate) oral solution, 25 mg/mL, 473 mL Bottle, Rx only, Manufactured for: Azurity Pharmaceuticals, Woburn, MA 01801, NDC 52652-9001-1

Distribution Pattern

USA nationwide.

Other Recalls by Azurity Pharmaceuticals, Inc.

Class I: Dangerous 01/04/2024

Labeling: Label Mix-up
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.