Is Eptifibatide recalled?

6 FDA recalls mention Eptifibatide. The most recent are listed below.

Recalls are matched by product description. A recall usually affects specific lots, not every package of Eptifibatide.

Class III · Low risk Ongoing Feb 12, 2026

Eptifibatide Injection, 75 mg/100 mL vial for weight-adjusted bolus dosing, 1x100 mL Single-dose Vial, For Intravenous Use Only…

Reason Labeling: Not Elsewhere Classified. The carton for Eptifibatide Injection 75 mg/100 mL states 75 mg/100 mL vial for weight-adjusted bolus dosing. The…

Slate Run Pharmaceuticals D-0343-2026

Class III · Low risk Ongoing May 22, 2024

Eptifibatide injection 20mg/10mL (2mg/mL), 10mL Single-Dose Vial, Rx only, Mfd. In India for: AuroMedics Pharma, LLC, E. Windsor…

Reason Failed Impurities/Degradation Specifications: failed related substance identified as Eptifibatide dimer.

Eugia US LLC NDC 55150-219-10 D-0556-2024

Class III · Low risk Terminated Aug 6, 2019

Eptifibatide Injection, a) 20 mg/10 mL (2 mg/mL),10 mL Single Use Vial, NDC 17478-902-10, b) 200 mg/100 mL (2 mg/mL), 100 mL…

Reason Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known impurity, D-aspartic acid.

Akorn, Inc. NDC 17478-902-10 D-1841-2019

Class III · Low risk Terminated Aug 6, 2019

Eptifibatide Injection, 75 mg/100 mL (0.75 mg/mL), 100 mL Single-use Vial, For Intravenous Use Only, Rx Only, Manufactured by…

Reason Short Fill: fill volume was out of specification at 94 mL (specification: no less than 100 mL) and Failed Impurities/Degradation Specifications: Out…

Akorn, Inc. NDC 17478-903-90 D-1840-2019

Class III · Low risk Terminated Aug 6, 2019

Eptifibatide Injection, 75 mg/100 mL (0.75 mg/mL), 100 mL Single-use Vial, For Intravenous Use Only, Rx Only, Manufactured by…

Reason Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known impurity, D-aspartic acid.

Akorn, Inc. NDC 17478-903-90 D-1839-2019

Class II · Moderate risk Terminated Jun 17, 2016

Eptifibatide Injection 75 mg/100 mL (0.75 mg/mL) single use vial, For Intravenous Use Only, Rx Only, Manufactured in Hungary for…

Reason CGMP Deviations

Teva North America NDC 0703-1179-01 D-1496-2016

Eptifibatide Injection, 75 mg/100 mL vial for weight-adjusted bolus dosing, 1x100 mL Single-dose Vial, For Intravenous Use Only…

Eptifibatide injection 20mg/10mL (2mg/mL), 10mL Single-Dose Vial, Rx only, Mfd. In India for: AuroMedics Pharma, LLC, E. Windsor…

Eptifibatide Injection, a) 20 mg/10 mL (2 mg/mL),10 mL Single Use Vial, NDC 17478-902-10, b) 200 mg/100 mL (2 mg/mL), 100 mL…

Eptifibatide Injection, 75 mg/100 mL (0.75 mg/mL), 100 mL Single-use Vial, For Intravenous Use Only, Rx Only, Manufactured by…

Eptifibatide Injection, 75 mg/100 mL (0.75 mg/mL), 100 mL Single-use Vial, For Intravenous Use Only, Rx Only, Manufactured by…

Eptifibatide Injection 75 mg/100 mL (0.75 mg/mL) single use vial, For Intravenous Use Only, Rx Only, Manufactured in Hungary for…

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