Exact FDA event identifier

Event 89457

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

Event summary

Timeline bucket: January 26, 2022
Product types: Drug
Classifications: Class I
Statuses: Terminated
Recalling firm wording: AuroMedics Pharma 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

Polymyxin B for Injection USP, 500,000 Units per Vial, 10 mL vials, packaged in 10 vials per carton, Sterile, Rx Only, Distributed by: AuroMedics Pharma LLC, E. Windsor, NJ 08520, NDC 55150-234-10

D-0556-2022

Recall number: D-0556-2022
Initiated: January 26, 2022
Classification: Class I
Status: Terminated
Recalling firm: AuroMedics Pharma LLC
Quantity: 35,520 vials

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0

Particulate Matter

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Presence of Particulate Matter; product complaint of hair discovered in a vial within the lot

Code information

Lot CPB200013, exp 9/2022

Distribution pattern

Nationwide in the US