Drug product
LET Topical Gel, Lidocaine HCL / Epinepherine / Tetracaine HCl, 4%/0.05%/0.5%, 3 mL per syringe, Single Dose Syringe for Topical Use, Edge Pharma, LLC, 856 Hercules Dr. Colchester, VT, NDC 05446-0607-01
D-0437-2022
Product summary
- Firm
- Edge Pharma, LLC
- Event
- Event 89172
- Status
- Terminated
- Classification
- Class II
- Quantity
- 26917 syringes
- Official record key
drug-enforcement:D-0437-2022
Official wording
Reason: CGMP Deviations
Code information: 07-2021-12@6 12-09-2021, 07-2021-19@7 12-16-2021, 07-2021-26@5 12-23-2021, 08-2021-02@8 12-30-2021, 08-2021-09@10 01-06-2022, 08-2021-13@6 01-10-2022, 08-2021-18@4 01-15-2022, 08-2021-24@8 01-21-2022, 08-2021-30@5 01-27-2022, 09-2021-07@11 02-04-2022, 09-2021-13@5 02-10-2022 & 10-2021-04@9 03-03-2022.
Distribution pattern: nationwide
Derived failure modes
-
Manufacturing or process control
CGMP Deviations