Drug product
Lidocaine HCl Sterile Buffered Solution for Injection (PF) 1%, 10mL per syringe, Single Use Syringe for Infiltration and Nerve Block, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-0850-10
D-0395-2022
Product summary
- Firm
- Edge Pharma, LLC
- Event
- Event 89172
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4465 syringes
- Official record key
drug-enforcement:D-0395-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: 08-2021-27@3 12/09/2021 09-2021-24@1 01/06/2022 10-2021-14@2 01/31/2022
Distribution pattern: nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility