Exact FDA event identifier

Event 78396

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

Event summary

Timeline bucket: October 27, 2017
Product types: Drug
Classifications: Class I
Statuses: Terminated
Recalling firm wording: Fresenius Kabi USA, LLC

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

Midazolam Injection, USP, Preservative Free, 2 mg / 2 mL (1 mg / mL), 24 X 2mL Prefilled single-use syringes per carton, Rx only, Fresenius Kabi Lake Zurich, IL 60047, NDC 76045-001-20

D-0152-2018

Recall number: D-0152-2018
Initiated: October 27, 2017
Classification: Class I
Status: Terminated
Recalling firm: Fresenius Kabi USA, LLC
Quantity: 203136 syringes

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

Labeling: Label MIX-UP

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling: Label MIX-UP. Blister Packages, Labeled as Midazolam injection, USP, 2 mg / 2 ml, Containing Syringes of Ondansetron Injection, USP, 4 mg / 2 mL

Code information

Lot: 6400048

Distribution pattern

Nationwide in the USA