Drug product
Tetracaine HCl Nasal Solution, 4%, 240 mL per bottle, Multiple Dose Container for Intranasal Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, 05446, NDC 05446-1195-03, packaged in bottles.
D-0447-2022
Product summary
- Firm
- Edge Pharma, LLC
- Event
- Event 89172
- Status
- Terminated
- Classification
- Class II
- Quantity
- 114 bottles
- Official record key
drug-enforcement:D-0447-2022
Official wording
Reason: CGMP Deviations
Code information: 06-2021-08@5 12-05-2021, 07-2021-07@7 01-03-2022, 07-2021-27@10 01-23-2022 & 10-2021-06@12 04-04-2022
Distribution pattern: nationwide
Derived failure modes
-
Manufacturing or process control
CGMP Deviations