Eagle Pharmaceuticals issued a recall for four lots of an anticoagulant due to visible particles in the solution that may cause adverse side effects in patients.
The Food and Drug Administration reported that the affected lots of Argatroban Injection 50 mg/50 ml (1 mg/mL) may lead to infarction or embolization to organs as well as organ complications. The lot numbers are V10189, V10191, and V10194, with an expiration date of January 2013, and V10223, with an expiration date of February 2013, according to Med Page Today.
There are no reports of adverse events associated with the recall.
Argatroban is used for prophylaxis or treatment of thrombosis in patients with herapin-induced thrombocytopenia as well as patients undergoing percutaneous coronary intervention.