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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 93552

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
December 08, 2023
Product types
Drug
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Azurity Pharmaceuticals, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 1

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
Recall number
D-0213-2024
Initiated
December 08, 2023
Classification
Class III
Status
Terminated
Quantity
2,220 bottles

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
Out of specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

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.

Code information

Lot #: MB22020B, Exp 12/27/2023

Distribution pattern

USA nationwide.