FDA recall D-0226-2021

Product

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

Reason for recall

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

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2020-03-19

Report date

2021-01-20

Termination date

2023-06-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

Colchester, VT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0226-2021