Drug product
ALUM Concentrate (Aluminum Potassium Sulfate Dodecahydrate in Sterile Water (PF) 30 g/300 ml, IV bag, Rx Only, Edge Pharma, LLC, 856 Hercules Dr, Colchester, VT 05446, NDC 05446-0637-03
D-0394-2022
Product summary
- Firm
- Edge Pharma, LLC
- Event
- Event 89172
- Status
- Terminated
- Classification
- Class II
- Quantity
- 30 bags
- Official record key
drug-enforcement:D-0394-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: 08-2021-25@2 12/08/2021 09-2021-08@1 12/23/2021 10-2021-20@3 02/01/2022
Distribution pattern: nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility