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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 88194

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

Open FDA event record

Event summary

Timeline bucket
June 25, 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

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

Xylocaine-MPF with Epinephrine 1:200,000, (Lidocaine HCl and Epinephrine Injection, USP), 1%, 300 mg/30 mL, (10 mg/mL), 30 mL Single Dose Vial, 25 Vials per Tray, Rx only, Fresenius Kabi USA, LLC, Lake Zurich, IL 60047. Vial NDC 63323-487-07, Tray NDC 63323-487-37

D-0651-2021
Recall number
D-0651-2021
Initiated
June 25, 2021
Classification
Class II
Status
Terminated
Recalling firm
Fresenius Kabi USA LLC
Quantity
234,800 vials

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0
out of specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Low out of specification results for epinephrine assay.

Code information

Batch, expiry: Batch 6123435, exp 01/2022; 6124730, 6124731, exp 07/2022

Distribution pattern

Distributed Nationwide in the USA