Methotrexate, USP, Sterile Solution for Injection (PF), 125 mg/5mL (2mg/mL), 5 mL per syringe, Ed...
FDA Recall #D-0406-2022 — Class II — December 6, 2021
Product Description
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 for Recall
Lack of Assurance of Sterility
Recalling Firm
Edge Pharma, LLC — Colchester, VT
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
457 syringes
Distribution
nationwide
Code Information
09-2021-10@2 12/23/2021, 10-2021-21@2 02/01/2022 & 11-2021-09@5 02/21/2022
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated