Drug product
Phenylephrine HCl, Sterile Solution for Injection, (PF), 800 mcg/10mL (80 mcg/mL), Single Use Syringe for IV Injection, Edge Pharma, LLC 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1652-01
D-0417-2022
Product summary
- Firm
- Edge Pharma, LLC
- Event
- Event 89172
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5335 syringes
- Official record key
drug-enforcement:D-0417-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: 08-2021-27@4 12/09/2021, 09-2021-17@1 12/30/2021, 10-2021-15@1 01/27/2022 & 10-2021-28@1 02/09/2022
Distribution pattern: nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility