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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 93113

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

Open FDA event record

Event summary

Timeline bucket
September 25, 2023
Product types
Drug
Classifications
Class I
Statuses
Completed
Recalling firm wording
Scynexis, 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

BREXAFEMME (Ibrexafungerp) tablets 150 mg, 4 count cartons, Rx Only, Manufactured for and distributed by SCYNEXIS, Inc., Jersey City, NJ 07302 NDC 75788-115-04

D-0042-2024
Recall number
D-0042-2024
Initiated
September 25, 2023
Classification
Class I
Status
Completed
Recalling firm
Scynexis, Inc.
Quantity
17,376

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Cross Contamination with Other Products: Potential cross-contamination of ibrexafungerp citrate drug substance with ezetimibe (a non-antibacterial beta-lactam compound).

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Cross Contamination with Other Products: Potential cross-contamination of ibrexafungerp citrate drug substance with ezetimibe (a non-antibacterial beta-lactam compound).

Code information

Lot# LF21000008, Exp. 11/30/2023 Lot# LF22000051, Exp. 11/30/2025

Distribution pattern

Nationwide in the US.