FDA Drug recall D-0389-2025
Tirofiban Hydrochloride Injection 5 mg/100 mL (50 mcg/mL), 100 mL single-dose container (bag), Rx only, Manufactured in India for: Eugia U.…
- FDA Drug
- Class II
- ongoing
- Published 2025-05-07
On 2025-05-07 the FDA classified a Class II recall of Tirofiban Hydrochloride Injection 5 mg/100 mL (50 mcg/mL), 100 mL single-dose container (bag), Rx only, Manufactured in India for: Eugia U.… by Eugia Us, citing out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0389-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-04-21 |
| Published | 2025-05-07 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Eugia Us |
| Distribution | US |
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
Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
Identifiers
| ndc | 55150-429-01 |
|---|---|
| ndc | 55150-430-01 |
| code_info | Lot #: 3TF24002A, Exp 11/30/2026 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0389-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.