Drug product
Lidocaine HCl/Epinephrine, Sterile Buffered Solution for Injection (PF) 1% / 1:100,000, 3 mL per syringe, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, (802) 992-1178, NDC 05446-1268-01
D-0396-2022
Product summary
- Firm
- Edge Pharma, LLC
- Event
- Event 89172
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8140 syringes
- Official record key
drug-enforcement:D-0396-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: 10-2021-25@4 12/08/2021 11-2021-08@6 12/22/2021
Distribution pattern: nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility