FDARecalled Jan 10, 2024 · #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
Hazard
Class III — low health risk
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Failed Impurities/Degradation Specifications: Out of specification Impurity C (4,5-desisopropylidene topiramate) result observed during routine stability testing at 18 months. Classification: Class III Distribution: USA nationwide.
Product details
- Product
- Eprontia (topiramate) oral solution, 25 mg/mL, 473 mL Bottle, Rx only, Manufactured for: Azurity Pharmaceuticals, Woburn, MA 01801, NDC 52652-9001-1
- Type
- Drugs
- Manufacturer
- Azurity Pharmaceuticals, Inc.
- Model numbers
- MB22020B
- UPCs
- —