Eprontia (topiramate) oral solution, 25 mg/mL, 473 mL Bottle, Rx only, Manufactured for: Azurity ...
FDA Recall #D-0213-2024 — Class III — December 8, 2023
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
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.
Recalling Firm
Azurity Pharmaceuticals, Inc. — Wilmington, MA
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
2,220 bottles
Distribution
USA nationwide.
Code Information
Lot #: MB22020B, Exp 12/27/2023
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated