Recalling firm
Eugia US LLC
Product type
Drug
Status
Ongoing
Report date
2025-05-07
Distribution
USA nationwide.
Firm state
NJ
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & QualificationReason 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 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
Code / lot info
Lot# : 3TF24001, Exp 3/31/2026
Other recalls SPEQ maps to Validation & Qualification
See all Validation & Qualification recalls →Data: U.S. FDA openFDA enforcement API. 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.