Product: Epoprostenol Sodium for Injection, 1.5 mg/vial (1,500,000 ng), 10 mL vial, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA  19454, NDC 0703-1995-01.
Reason for recall: Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Recall initiated: 20210210
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated