Exact FDA event identifier

Event 92458

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

Event summary

Timeline bucket: June 12, 2023
Product types: Drug
Classifications: Class III
Statuses: Terminated
Recalling firm wording: Amring 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

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

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

Lysteda (tranexamic acid) USP Tablets, 650 mg, 30 tablets per bottle, Rx Only, Manufactured for: Amring Pharmaceuticals Inc. Berwyn, PA 19312, NDC 69918-301-30

D-0871-2023

Recall number: D-0871-2023
Initiated: June 12, 2023
Classification: Class III
Status: Terminated
Recalling firm: Amring Pharmaceuticals Inc
Quantity: 48,989 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 results obtained for conductivity.

Code information

Lots: X220317A and X220318A, exp. date 09/25

Distribution pattern

Nationwide in the USA.