FDA-Drug2021-01-20Class II
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
Edge Pharma, LLC
Hazard
Lack of Assurance of Sterility; the media used to conduct post-compounding sterility testing for the Methotrexate product was expired.
Sold states
Nationwide
Affected count
71 syringes
Manufactured in
856 Hercules Dr, N/A, Colchester, VT, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0226-2021Don't want to check this manually?
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