Reported Jan 20, 2021 · Terminated
Methotrexate, USP Sterile Solution for Injection, Preservative Free 125mg/5ml (25mg/ml), 5 mL per syringe, Rx Only,…
Edge Pharma, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Edge Pharma, LLC · 856 Hercules Dr · Colchester, VT · 05446-8014
Is this the product you have?
- 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
- Lot codes and dates
- Lot# 01-2020-28@10
- Amount recalled
- 71 syringes
Where it was sold
- Nationwide
Why it was recalled
Lack of Assurance of Sterility; the media used to conduct post-compounding sterility testing for the Methotrexate product was expired.
This product could cause temporary or reversible health problems — stop using it.
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