Drug product
Phenylephrine HCl 0.5 mg/5mL, (0.1 mg/mL), 5 mL per syringe, Single Use Syringe for IV Injection, Edge Pharma, LLC, 856 Hercules Dr, Colchester, VT 05446, NDC 05446-1545-05
D-0415-2022
Product summary
- Firm
- Edge Pharma, LLC
- Event
- Event 89172
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3747 syringes
- Official record key
drug-enforcement:D-0415-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: 09-2021-09@4 12/22/2021 & 10-2021-14@1 01/26/2022
Distribution pattern: nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility