Drug product
Edetate Disodium (EDTA), Sterile Ophthalmic Solution (PF) 1.5%, 10 mL per dropper, Single Dose Droptainer for Topical Ophthalmic Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, 05446, NDC 05446-1427-10
D-0400-2022
Product summary
- Firm
- Edge Pharma, LLC
- Event
- Event 89172
- Status
- Terminated
- Classification
- Class II
- Quantity
- 80 droppers
- Official record key
drug-enforcement:D-0400-2022
Official wording
Reason: Lack of Assurance of Sterility.
Code information: 10-2021-20@1 02/10/2022
Distribution pattern: nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility