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Class II Recall
Edge Pharma, LLC
Product
Mitomycin-C, 40mg/40mL (1mg/mL), 40 mL per syringe, Single Dose Syringe for Intravesical Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1416-01
Reason
Lack of Assurance of Sterility
Classification
Class II
Status
Terminated
Lot
08-2021-24@5 12/09/2021, 08-2021-27@2 12/21/2021, 08-2021-31@5 12/14/2021, 09-2021-02@2 12/15/2021, 09-2021-09@2 12/22/2021, 09-2021-15@3 12/29/2021, 09-2021-22@2 01/04/2022 & 10-2021-26@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.