Exact FDA event identifier

Event 94075

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

Event summary

Timeline bucket: February 20, 2024
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

Methylprednisolone acetate Injectable Suspension, USP, 400mg per 5mL (80mg/mL, 5mL Multiple-Dose Vial, Rx only, Mfd. in India for: Eugia US LLC, E. Windsor, NJ 08520, NDC 55150-314-01

D-0366-2024

Recall number: D-0366-2024
Initiated: February 20, 2024
Classification: Class II
Status: Ongoing
Recalling firm: Eugia US LLC
Quantity: 10,080 vials

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

Failed Dissolution Specifications

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Dissolution Specifications

Code information

Lot #: 3MA23001, 3MA23002, 3MA23003, Exp 3/31/2025

Distribution pattern

OH, TN, LA, MS