FDAFDA · Food and drugs·Recall number D-0213-2024
Eprontia (topiramate) oral solution, 25 mg/mL, 473 mL Bottle, Rx only, Manufactured for: Azurity Pharmaceuticals, Woburn, MA 01801, NDC 52652-9001-1
Published January 10, 2024 · Recall initiated: December 8, 2023
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradation Specifications: Out of specification Impurity C (4,5-desisopropylidene topiramate) result observed during routine stability testing at 18 months.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- EPRONTIA
- Manufacturer
- Azurity Pharmaceuticals, Inc.
- Distributor
- USA nationwide.
- Lot
- Lot #: MB22020B, Exp 12/27/2023
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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