Drug product
Phenylephrine HCl, 1mg/10mL (0.1mg/mL), 10 mL per syringe, Single Use Syringe for IV Injection, Edge Pharma, LLC, 856 Hercules Dr, Colchester, VT 05446 NDC 05446-1544-10
D-0416-2022
Product summary
- Firm
- Edge Pharma, LLC
- Event
- Event 89172
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6535 vials
- Official record key
drug-enforcement:D-0416-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: 08-2021-26@3 12/16/2021, 09-2021-16@5 12/29/2021, 10-2021-07@2 01/19/2022 & 10-2021-22@1 02/03/2022.
Distribution pattern: nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility