Exact FDA event identifier

Event 82915

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

Event summary

Timeline bucket: May 22, 2019
Product types: Drug
Classifications: Class III
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

Ondansetron Injection, USP, 40 mg / 20 mL, 20 mL vial, Rx Only, Fresenius Kabi USA, LLC, Lake Zurich, IL 60047, NDC 63323-374-20

D-1386-2019

Recall number: D-1386-2019
Initiated: May 22, 2019
Classification: Class III
Status: Terminated
Recalling firm: Fresenius Kabi USA, LLC
Quantity: 11,981 units

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

Failed Impurities/Degradation Specifications

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Impurities/Degradation Specifications.

Code information

Lot #: 6018699, Exp. 12/2021

Distribution pattern

Nationwide within the United States