Drug product
LT Topical Cream, Lidocaine/Tetracaine, 23%/7%, 60gm per jar, Multiple Dose Container for Topical Use, Edge Pharma, LLC, 856 Hercules, VT, Colchester, VT 05446, NDC 05446-1647-01
D-0436-2022
Product summary
- Firm
- Edge Pharma, LLC
- Event
- Event 89172
- Status
- Terminated
- Classification
- Class II
- Quantity
- 74 jars
- Official record key
drug-enforcement:D-0436-2022
Official wording
Reason: CGMP Deviations
Code information: 08-2021-23@9 02-19-2022, 09-2021-07@13 03-06-2022 & 10-2021-22@5 04-20-2022.
Distribution pattern: nationwide
Derived failure modes
-
Manufacturing or process control
CGMP Deviations