Class II
Ongoing
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
This recall is currently active, issued May 7, 2025. It was issued by Eugia Us Llc.
- Company
- Eugia Us Llc
- Recall Initiated
- April 21, 2025
- Posted
- May 7, 2025
- Recall Number
- D-0389-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 18,867 bags
- Firm Location
- East Windsor, NJ, United States
- Official Source
- View on FDA website ↗
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.
Lot / Code Info
Lot #: 3TF24002A, Exp 11/30/2026
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