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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 92535

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

Open FDA event record

Event summary

Timeline bucket
June 13, 2023
Product types
Drug
Classifications
Class III
Statuses
Ongoing
Recalling firm wording
AVKARE LLC

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

Tranexamic Acid USP Tablets, 650 mg, 30 tablets (3X10) Unit Dose, Rx Only, Manufactured for: AvKARE Pulaski, TN 38478, NDC 50268-772-13

D-0875-2023
Recall number
D-0875-2023
Initiated
June 13, 2023
Classification
Class III
Status
Ongoing
Recalling firm
AVKARE LLC
Quantity
592 cartons

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 results obtained for conductivity.

Code information

Lot: 44286 Exp. 02/2025

Distribution pattern

Nationwide in the USA.