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FDAMarch 19, 2020drug

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 recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

edge pharmaedge

UPCs

18029921178

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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