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Recall Observatory FDA recall evidence

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

December 08, 2023

Class III

Product summary

Firm
Azurity Pharmaceuticals, Inc.
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

    reason.potency_specification_failure · v1.0.0

    Out of specification