Exact FDA event identifier

Event 93747

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

Event summary

Timeline bucket: January 10, 2024
Product types: Drug
Classifications: Class II
Statuses: Terminated
Recalling firm wording: BE PHARMACEUTICALS AG

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

Fosaprepitant for Injection 150 mg per vial, Sterile lyophilized powder for Intravenous use only after reconstitution and dilution, Single Dose Vial, Rx Only, Distributed by BE Pharmaceuticals Inc. 203 New Edition Court Cary, NC 27511, Made in India, NDC 71839-104-01.

D-0262-2024

Recall number: D-0262-2024
Initiated: January 10, 2024
Classification: Class II
Status: Terminated
Recalling firm: BE PHARMACEUTICALS AG
Quantity: 22,176 Vials

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0

Lack of Sterility

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Lack of Sterility Assurance: Aseptic process simulation failure.

Code information

lot #13D012AA, Exp: 08/31/2025

Distribution pattern

Nationwide in the USA