Exact FDA event identifier

Event 91643

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

Event summary

Timeline bucket: February 03, 2023
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Leadiant Biosciences, 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

Abelcet (Amphotericin B Lipid Complex) Injection, 5 mg/mL, 100 mg vial, Rx only, Manufactured by Exelead, Inc., Indianapolis, IN 46268; Distributed by Leadiant Biosciences, Inc., Gaithersburg, MD 20878, NDC 57665-101-41

D-0327-2023

Recall number: D-0327-2023
Initiated: February 03, 2023
Classification: Class II
Status: Terminated
Recalling firm: Leadiant Biosciences, Inc.
Quantity: 31,879 vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

Lack of assurance of sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of assurance of sterility: Medial fill with presence of Cupriavidus pauculus.

Code information

Lot#: 1203A, Exp. 5/11/2024

Distribution pattern

Nationwide USA