FDA Drugs recall ·
Tirofiban Hydrochloride Injection 5 mg/100 mL (50 mcg/mL)… recall
- Recall number
- D-0389-2025
- Date
- (initiated April 21, 2025)
- Company / brand
- Eugia US LLC
279 Princeton Hightstown Rd, East Windsor, NJ, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 18,867 bags
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot #: 3TF24002A, Exp 11/30/2026
Distribution
USA nationwide.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0389-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.