Drug product
Mitomycin-C, 40mg/40mL (1mg/mL), 40 mL per syringe, Single Dose Syringe for Intravesical Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1416-01
D-0407-2022
Product summary
- Firm
- Edge Pharma, LLC
- Event
- Event 89172
- Status
- Terminated
- Classification
- Class II
- Quantity
- 860 syringes
- Official record key
drug-enforcement:D-0407-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: 08-2021-24@5 12/09/2021, 08-2021-27@2 12/21/2021, 08-2021-31@5 12/14/2021, 09-2021-02@2 12/15/2021, 09-2021-09@2 12/22/2021, 09-2021-15@3 12/29/2021, 09-2021-22@2 01/04/2022 & 10-2021-26@5 02/07/2022
Distribution pattern: nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility