Drug product
Cefuroxime, Sterile Ophthalmic Solution for Injection, Preservative Free, 3mg/0.3mL (10 mg/mL), 0.3 mL single use syringe for Intraocular Injection, Edge Pharma, LLC, 656 Hercules Dr., Colchester, VT 05446 NDC 05446-1003-01
D-0398-2022
Product summary
- Firm
- Edge Pharma, LLC
- Event
- Event 89172
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1720 syringes
- Official record key
drug-enforcement:D-0398-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: 08-2021-30@1 12/20/2021, 09-2021-21@5 01/03/2022 & 10-2021-18@5 02/07/2022
Distribution pattern: nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility