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Class II Recall
Edge Pharma, LLC
Product
Methotrexate, USP, Sterile Solution for Injection (PF), 125 mg/5mL (2mg/mL), 5 mL per syringe, Edge Pharma, LLC, 856 Hercules Dr, Colchester, VT 05446, NDC 05446-1505-05
Reason
Lack of Assurance of Sterility
Classification
Class II
Status
Terminated
Lot
09-2021-10@2 12/23/2021, 10-2021-21@2 02/01/2022 & 11-2021-09@5 02/21/2022
Date
2022-02-02
Disclaimer:
This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.