Drug product
Eprontia (topiramate) oral solution, 25 mg/mL, 473 mL Bottle, Rx only, Manufactured for: Azurity Pharmaceuticals, Woburn, MA 01801, NDC 52652-9001-1
D-0213-2024
Product summary
- Event
- Event 93552
- Status
- Terminated
- Classification
- Class III
- Quantity
- 2,220 bottles
- Official record key
drug-enforcement:D-0213-2024
Official wording
Reason: Failed Impurities/Degradation Specifications: Out of specification Impurity C (4,5-desisopropylidene topiramate) result observed during routine stability testing at 18 months.
Code information: Lot #: MB22020B, Exp 12/27/2023
Distribution pattern: USA nationwide.
Derived failure modes
-
Potency or specification failure
Out of specification