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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 96718

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
April 21, 2025
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

Complete imported group

Every recalled product in this event

2 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 2

Tirofiban Hydrochloride Injection 5 mg/100 mL (50 mcg/mL), 100 mL single-dose container (bag), Rx only, Manufactured in India for: Eugia U.S. LLC, 279 Princeton-Hightstown Rd., E. Windsor, NJ 08520, NDC 55150-429-01

D-0389-2025
Recall number
D-0389-2025
Initiated
April 21, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Eugia US LLC
Quantity
18,867 bags

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

Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.

Code information

Lot #: 3TF24002A, Exp 11/30/2026

Distribution pattern

USA nationwide.

drug · product 2 of 2

Tirofiban Hydrochloride Injection 12.5 mg/250 mL (50 mcg/mL), 250 mL single-dose container (bag), Rx only, Manufactured in India for: Eugia U.S. LLC, 279 Princeton-Hightstown Rd., E. Windsor, NJ 08520, NDC 55150-430-01

D-0390-2025
Recall number
D-0390-2025
Initiated
April 21, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Eugia US LLC
Quantity
Unavailable

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

Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.

Code information

Lot# : 3TF24001, Exp 3/31/2026

Distribution pattern

USA nationwide.