Drug product
Vancomycin HCl in 0.9% Sodium Chloride Injection, USP, 1,750mg/500mL, Single Use Bag for IV Injection (Preservative Free), 500 mL pre-filled bag, Rx Only, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446 NDC 05446-1459-01
D-0427-2022
Product summary
- Firm
- Edge Pharma, LLC
- Event
- Event 89172
- Status
- Terminated
- Classification
- Class II
- Quantity
- 749 bags
- Official record key
drug-enforcement:D-0427-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: 09-2021-09@6 12/23/2021 & 10-2021-13@5 01/27/2022
Distribution pattern: nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility