Drug product
Lidocaine HCl/Phenylephrine HCl Nasal Solution, 4%/1%, 240 mL per bottle, Multiple Dose Container, Edge Pharma, LLC 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1045-03
D-0444-2022
Product summary
- Firm
- Edge Pharma, LLC
- Event
- Event 89172
- Status
- Terminated
- Classification
- Class II
- Quantity
- 231 bottles
- Official record key
drug-enforcement:D-0444-2022
Official wording
Reason: CGMP Deviations
Code information: 07-2021-02@7 12-29-2021, 07-2021-23@4 01-19-2022, 08-2021-11@7 02-07-2022, 08-2021-23@8 02-19-2022 & 09-2021-24@10 03-23-2022
Distribution pattern: nationwide
Derived failure modes
-
Manufacturing or process control
CGMP Deviations