Exact FDA event identifier

Event 88698

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

Event summary

Timeline bucket: September 17, 2021
Product types: Drug
Classifications: Class II
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

Morphine Sulfate Injection, USP, 2 mg per mL, 1 mL single dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-452-01. 25 vials per tray packaged 18 trays per shipper

D-0856-2021

Recall number: D-0856-2021
Initiated: September 17, 2021
Classification: Class II
Status: Terminated
Recalling firm: Fresenius Kabi USA LLC
Quantity: 963000 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

Defective container: Cracked vials leading to lack of sterility assurance

Code information

Lot # 6023731, 6023732, Exp 03/2023; 6024172, 6024260, Exp 06/2023

Distribution pattern

U.S.A. Nationwide