Methotrexate, USP Sterile Solution for Injection, Preservative Free 125mg/5ml (25mg/ml), 5 mL per syringe, Rx Only, SYRINGE FOR IM INJECTION, Edge Pharma, LLC 856 Hercules Dr. Colchester, VT 05446 Customer Service (USA) 1-802-992-1178, Barcode 0544650505

Recall Number: D-0226-2021

Firm: Edge Pharma, LLC

Classification: Class II

Status: Terminated

Report Date: 20210120

Initiation Date: 20200319

Termination Date: 20230607

Lack of Assurance of Sterility; the media used to conduct post-compounding sterility testing for the Methotrexate product was expired.

Methotrexate, USP Sterile Solution for Injection, Preservative Free 125mg/5ml (25mg/ml), 5 mL per syringe, Rx Only, SYRINGE FOR IM INJECTION, Edge Pharma, LLC 856 Hercules Dr. Colchester, VT 05446 Customer Service (USA) 1-802-992-1178, Barcode 0544650505