D-0213-2024 Class III Terminated
FDA drug recall D-0213-2024 was initiated by Azurity Pharmaceuticals, Inc. on Dec 8, 2023 and is designated Class III. 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. The recall status is terminated (terminated Apr 24, 2024). Affected quantity: 2,220 bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Jan 10, 2024
- Initiation Date
- Dec 8, 2023
- Termination Date
- Apr 24, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,220 bottles
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.
Distribution pattern
USA nationwide.
Code information
Lot #: MB22020B, Exp 12/27/2023
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0213-2024
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026