FDA recall D-0389-2025

Product

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

Reason for recall

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

Distribution

USA nationwide.

Key facts

Status

Ongoing

Initiation date

2025-04-21

Report date

2025-05-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

East Windsor, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0389-2025