Drug product
Methotrexate, USP, Sterile Solution for Injection (PF), 125 mg/5mL (2mg/mL), 5 mL per syringe, Edge Pharma, LLC, 856 Hercules Dr, Colchester, VT 05446, NDC 05446-1505-05
D-0406-2022
Product summary
- Firm
- Edge Pharma, LLC
- Event
- Event 89172
- Status
- Terminated
- Classification
- Class II
- Quantity
- 457 syringes
- Official record key
drug-enforcement:D-0406-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: 09-2021-10@2 12/23/2021, 10-2021-21@2 02/01/2022 & 11-2021-09@5 02/21/2022
Distribution pattern: nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility