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
Reported: May 7, 2025 Initiated: April 21, 2025 #D-0389-2025
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.
Details
- Recalling Firm
- Eugia US LLC
- Units Affected
- 18,867 bags
- Distribution
- USA nationwide.
- Location
- East Windsor, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Eugia US LLC. Units affected: 18,867 bags.
Why was this product recalled? ▼
Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 7, 2025. Severity: Moderate. Recall number: D-0389-2025.
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