Exact FDA event identifier

Event 86095

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

Event summary

Timeline bucket: July 22, 2020
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

Dexmedetomidine HCl in 0.9% Sodium Chloride Injection, 200 mcg per 50 mL (4 mcg per mL), for intravenous infusion, preservative free, 50 mL Single Dose Bottle, Rx only, Fresenius Kabi Lake Zurich, IL 60047, NDC 63323-671-05

D-1537-2020

Recall number: D-1537-2020
Initiated: July 22, 2020
Classification: Class I
Status: Terminated
Recalling firm: Fresenius Kabi USA, LLC
Quantity: 25,100 bottles

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Cross Contamination with other products: trace amounts of lidocaine

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 lidocaine

Code information

Lot #: 6121853, Exp 05/2021; 6122207, Exp 06/2021

Distribution pattern

U.S.A. Nationwide