Exact FDA event identifier

Event 94528

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

Event summary

Timeline bucket: April 30, 2024
Product types: Drug
Classifications: Class III
Statuses: Completed
Recalling firm wording: Hikma Injectables USA 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

Fentanyl 1000mcg/100mL (10mcg/mL) in 0.9% Sodium Chloride Injection, packaged in 100mL bags, Rx only, Compounded by: Hikma Injectables USA Inc. 2 Esterbrook Lane, Cherry Hill, NJ 08003, Distributed by: Hikma Injectables USA Inc. 36 Stults Road, Dayton, NJ 08810, NDC 63037-100-05

D-0480-2024

Recall number: D-0480-2024
Initiated: April 30, 2024
Classification: Class III
Status: Completed
Recalling firm: Hikma Injectables USA Inc
Quantity: 1,895 bags

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

Labeling: Wrong

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling: Wrong Barcode

Code information

Lot #: CH0324001, Exp. Date 3/4/2025

Distribution pattern

Nationwide within the United States