Drug product
Phenol, Sterile Solution for Injection (PF), 6%, 5 mL per vial, Single Use Vial for Perineural Injection, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1476-05, packaged in vials.
D-0413-2022
Product summary
- Firm
- Edge Pharma, LLC
- Event
- Event 89172
- Status
- Terminated
- Classification
- Class II
- Quantity
- 309 vials
- Official record key
drug-enforcement:D-0413-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: 09-2021-14@5 12/29/2021, 10/21/21 & 11-2021-04@2, 02/15/2022
Distribution pattern: nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility