Drug product
Ceftazidime, Sterile Ophthalmic Solution for Injection, Preservative Free (11.25 mg/0.5 mL (22.5 mg/mL), 0.5mL single use syringe for Intraocular Injection, Edge Pharma, LLC, 656 Hercules Dr., Colchester, VT 05446, NDC 05446-0733-01
D-0397-2022
Product summary
- Firm
- Edge Pharma, LLC
- Event
- Event 89172
- Status
- Terminated
- Classification
- Class II
- Quantity
- 168 syringes
- Official record key
drug-enforcement:D-0397-2022
Official wording
Reason: Lack of Assurance of Sterility
Code information: 09-2021-01@6 12/14/2021 & 10-2021-27@4 01/01/2022
Distribution pattern: nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility