Exact FDA event identifier

Event 91406

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

Event summary

Timeline bucket: December 28, 2022
Product types: Drug
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: Eugia US 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

Acyclovir Sodium Injection 1,000 mg per 20 mL* (50 mg/mL); Single Dose 20mL Vial, Rx only, Distributed by: AuroMedics Pharma LLC, 279 Princeton-Hightstown Rd, E. Windsor, NJ 08520; Made in India. NDC 55150-155-20

D-0095-2023

Recall number: D-0095-2023
Initiated: December 28, 2022
Classification: Class II
Status: Ongoing
Recalling firm: Eugia US LLC
Quantity: 45,250 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: Customer complaint of dark particles found inside the vial

Code information

Lot # AC22004, Expiry: 08/2023

Distribution pattern

Nationwide in the USA