Drug product
Vancomycin HCl in 0.9% Sodium Chloride Injection, 1,500 mg/500 mL, USP, Single Use Bag for IV Injection (Preservative Free), 500 mL pre-filled bag, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1458-01
D-0426-2022
Product summary
- Firm
- Edge Pharma, LLC
- Event
- Event 89172
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1825 bags
- Official record key
drug-enforcement:D-0426-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: 08-2021-26@4 12/08/2021 & 09-2021-21@3 01/04/2022
Distribution pattern: nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility