Drug 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
D-0226-2021
Product summary
- Firm
- Edge Pharma, LLC
- Event
- Event 87115
- Status
- Terminated
- Classification
- Class II
- Quantity
- 71 syringes
- Official record key
drug-enforcement:D-0226-2021
Official wording
Reason: Lack of Assurance of Sterility; the media used to conduct post-compounding sterility testing for the Methotrexate product was expired.
Code information: Lot# 01-2020-28@10
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility