Tirofiban Injection, Solution
FDA Recall NDC 55150-430
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Tirofiban (NDC 55150-430). A significant event, classified as Class II, was initiated on Apr 21, 2025 by Eugia Us Llc. The reported reason for this action was: "Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
April 2025 Class II Recall: Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
Recall Number
Class II Ongoing
Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
Apr 21, 2025
May 07, 2025
N/A
Recall Profile & Regulatory Data
Event ID
96718
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Eugia US LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA nationwide.
Product Description
Tirofiban Hydrochloride Injection 12.5 mg/250 mL (50 mcg/mL), 250 mL single-dose container (bag), Rx only, Manufactured in India for: Eugia U.S. LLC, 279 Princeton-Hightstown Rd., E. Windsor, NJ 08520, NDC 55150-430-01
Batch or Lot Expiration Information
Lot# : 3TF24001, Exp 3/31/2026
Affected Packages Involved in this Recall
55150-429-01Product
55150-430-01Product
April 2025 Class II Recall: Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
Recall Number
Class II Ongoing
Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
Apr 21, 2025
May 07, 2025
18,867 bags
Recall Profile & Regulatory Data
Event ID
96718
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Eugia US LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA nationwide.
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
Batch or Lot Expiration Information
Lot# : 3TF24002A, Exp 11/30/2026
Affected Packages Involved in this Recall
55150-429-01Product
55150-430-01Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
