Exact FDA event identifier

Event 90897

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

Event summary

Timeline bucket: September 26, 2022
Product types: Drug
Classifications: Class III
Statuses: Ongoing
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

Tranexamic Acid Injection, USP, 1000mg per 10 mL (100mg /mL), 10mL single-dose vial, Rx Only, Distributed by: AuroMedics Pharma LLC E. Windsor, NJ 08520, Made in India, NDC 55150-188-10

D-1551-2022

Recall number: D-1551-2022
Initiated: September 26, 2022
Classification: Class III
Status: Ongoing
Recalling firm: AuroMedics Pharma LLC
Quantity: 88080 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: Piece of metal found in a vial

Code information

Lot: CTA210006, Exp. 02/2024

Distribution pattern

Distributed Nationwide in the USA