← FDA ENFORCEMENT
D-0389-2025Class II

Eugia US LLC

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Eugia US LLC
Product type
Drug
Status
Ongoing
Report date
2025-05-07
Distribution
USA nationwide.
Firm state
NJ
Product quantity
18,867 bags
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
Reason for recall

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

Product description

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

Code / lot info

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

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →