Eagle Pharmaceuticals has issued a voluntary recall of four lots of Argatroban Injection 50mg/50mL (1mg/1mL) due to a potential for visible particulates. During an investigation, a visible particulate was discovered in a stability sample in one of the distributed lots. Upon re-inspection, a small number of visible particulates were discovered in several vials. The risk of using an injectable product with particulates includes embolization/infarction to organs and potential organ complications.
The affected products include NDC# 42367-203-07 (single unit) and NDC# 42367-203-84 (10 pack). Eagle Pharmaceuticals directed The Medicines Company to arrange for the return of the affected product lots from all services and facilities.
Argatroban is an anticoagulant indicated for prophylaxis and treatment of thrombosis in heparin-induced thrombocytopenia (HIT) or in those with or at risk of HIT undergoing percutaneous coronary intervention (PCI).
For more information visit http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm297100.htm.