Drug product
PHENYLephrine, 0.9% Sodium Chloride Injection, USP, 20 mg/250mL, (0.08 mg/mL), Single use bag for IV injection (Preservative Free), Rx Only, Edge Pharma, LLC, 856 Hercules Dr, Colchester, VT NDC 05446-1667-01
D-0418-2022
Product summary
- Firm
- Edge Pharma, LLC
- Event
- Event 89172
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3930 bags
- Official record key
drug-enforcement:D-0418-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: 08-2021-24@6 12/06/2021, 08-2021-31@7 12/12/2021, 09-2021-07@3 12/21/2021, 10-2021-20@2 02/02/2022 & 10-2021-28@2 02/10/2022.
Distribution pattern: nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility