D-0389-2025 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- May 7, 2025
- Initiation Date
- April 21, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 18,867 bags
Product Description
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 Pattern
USA nationwide.
Code Information
Lot #: 3TF24002A, Exp 11/30/2026