Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Failed Impurities/Degradation Specifications: failed related substance identified as Eptifibatide dimer.
Eptifibatide injection 20mg/10mL (2mg/mL), 10mL Single-Dose Vial, Rx only, Mfd. In India for: AuroMedics Pharma, LLC, E. Windsor, NJ 08520, NDC 55150-219-10
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
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…
Reason Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known impurity, D-aspartic acid.
Reason Short Fill: fill volume was out of specification at 94 mL (specification: no less than 100 mL) and Failed Impurities/Degradation Specifications: Out…
Reason Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known impurity, D-aspartic acid.
Reason CGMP Deviations
Tell us which medications you take. If the FDA recalls one, we email you - in plain English, with what to do. Free.