Exact FDA event identifier

Event 69810

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

Event summary

Timeline bucket: November 12, 2014
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

GENTAMICIN INJECTION, USP, equivalent to 40 mg/mL, Rx only, 20 mL Multiple Dose Vial, Manufactured by APP Pharmaceuticals, LLC, Schaumburg, IL 60173, NDC 63323-010-20

D-0290-2015

Recall number: D-0290-2015
Initiated: November 12, 2014
Classification: Class II
Status: Terminated
Recalling firm: Fresenius Kabi USA, LLC
Quantity: 92,125 vials

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Defective Container: Vials may be missing stoppers.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Defective Container: Vials may be missing stoppers.

Code information

Product Code: 1020; NDC: 63323-010-20; Lot Number: 6107992; Expiration Date: 09/2015

Distribution pattern

Nationwide and Puerto Rico