Tirofiban Hydrochloride Injection 5 mg/100 mL (50 mcg/mL), 100 mL single-dose container (bag), Rx only, Manufactured in
Summary
The FDA issued a Class II for Tirofiban Hydrochloride Injection 5 mg/100 mL (50 mcg/mL), 100 mL single-dose co by Eugia US LLC. Reason: Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances..
Details
Source
Drug Recall
External ID
D-0389-2025
Action Date
2025-05-07
Status
Ongoing
Category
drug
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
Lot/Code Info: Lot #: 3TF24002A, Exp 11/30/2026
Quantity Affected: 18,867 bags
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-04-21
Company
East Windsor, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 49 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Eugia US LLC has 17 FDA actions in our database, including 17 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Eugia US LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Eugia US LLC have FDA actions?
Eugia US LLC has 17 FDA actions in our database, including 17 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0389-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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