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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 95217

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

Open FDA event record

Event summary

Timeline bucket
August 24, 2024
Product types
Drug
Classifications
Class III
Statuses
Ongoing
Recalling firm wording
Rubicon Research Private Limited

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

AcetaZOLAMIDE Tablets, USP, 125 mg, 100 count bottled, Rx Only, Distributed by: Advagen Pharma Limited, Plainsboro, NJ, Manufactured by Rubicon Research Private Limited, Thane, India NDC 72888-047-01

D-0659-2024
Recall number
D-0659-2024
Initiated
August 24, 2024
Classification
Class III
Status
Ongoing
Quantity
3,984 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Discoloration

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Discoloration

Code information

Lot # 30575HF1, exp. date, Nov 2026 NDC# 72888-047-01

Distribution pattern

Nationwide in the US