Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Short Fill: fill volume was out of specification at 94 mL (specification: no less than 100 mL) and Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known impurity, D-aspartic acid.
Cause type: Failed specification
A physical or chemical test other than potency, dissolution, impurity or stability failed - pH, viscosity, appearance, tablet integrity, fill volume. A product outside its own specification may not perform as designed, even if the active ingredient is present. All failed specification recalls.
Eptifibatide Injection, 75 mg/100 mL (0.75 mg/mL), 100 mL Single-use Vial, For Intravenous Use Only, Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045, NDC 17478-903-90.
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Drug: Eptifibatide
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
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 approved statement is 75 mg/100 mL vial for weight-adjusted infusion.
Failed Impurities/Degradation Specifications: failed related substance identified as Eptifibatide dimer.
Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known impurity, D-aspartic acid.
Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known impurity, D-aspartic acid.
CGMP Deviations
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
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