Eprontia Solution
FDA Recall NDC 52652-9001
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Eprontia (NDC 52652-9001). A significant event, classified as Class III, was initiated on Dec 08, 2023 by Azurity Pharmaceuticals, Inc.. The reported reason for this action was: "Failed Impurities/Degradation Specifications: Out of specification Impurity C (4,5-desisopropylidene topiramate) result observed during routine stability testing at 18 months."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
December 2023 Class III Recall: Failed Impurities/Degradation Specifications
Recall Number
Class III Terminated
Failed Impurities/Degradation Specifications: Out of specification Impurity C (4,5-desisopropylidene topiramate) result observed during routine stability testing at 18 months.
Dec 08, 2023
Jan 10, 2024
2,220 bottles
Recall Profile & Regulatory Data
Event ID
93552
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Azurity Pharmaceuticals, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA nationwide.
Termination Date
Apr 24, 2024
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
Batch or Lot Expiration Information
Lot# : MB22020B, Exp 12/27/2023
Affected Packages Involved in this Recall
52652-9001-1Product
52652-9001-2Product
52652-9001-3Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
