Class III

Drug Recall: Eprontia (topiramate) oral solution, 25 mg/mL, 473 mL Bottle, Rx only, Manufactured for: Azurity Pharmaceuticals, Woburn, MA 01801, NDC 52652-9001-1

Azurity Pharmaceuticals, Inc. · December 8, 2023

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

USA nationwide.

States Affected

NATIONWIDE

Quantity Affected

2,220 bottles

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0213-2024

Status: terminated

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