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Class II Recall
Edge Pharma, LLC
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
Reason
Lack of Assurance of Sterility
Classification
Class II
Status
Terminated
Lot
08-2021-30@1 12/20/2021, 09-2021-21@5 01/03/2022 & 10-2021-18@5 02/07/2022
Date
2022-02-02
Disclaimer:
This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.