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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 86765

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

Open FDA event record

Event summary

Timeline bucket
November 17, 2020
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

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

DOXOrubicin Hydrochloride Injection, USP, 10 mg / 5 mL (2 mg / mL), 5 mL fill in a 6 mL vial, Single Dose Vial, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047. NDC: 63323-883-05

D-0105-2021
Recall number
D-0105-2021
Initiated
November 17, 2020
Classification
Class III
Status
Terminated
Recalling firm
Fresenius Kabi USA, LLC
Quantity
16,986 vials

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Cross Contamination with Other Products: trace amounts of octreotide found during testing

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Cross Contamination with Other Products: trace amounts of octreotide found during testing

Code information

Batch: 6120525, exp 11/2020

Distribution pattern

Nationwide USA and Puerto Rico

Field note

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