PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: February 2, 2022 Initiated: December 6, 2021 #D-0406-2022

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

Details

Recalling Firm
Edge Pharma, LLC
Units Affected
457 syringes
Distribution
nationwide
Location
Colchester, VT

Frequently Asked Questions

What product was recalled?
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. Recalled by Edge Pharma, LLC. Units affected: 457 syringes.
Why was this product recalled?
Lack of Assurance of Sterility
Which agency issued this recall?
This recall was issued by the FDA Drug on February 2, 2022. Severity: Moderate. Recall number: D-0406-2022.