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Class II Recall
Edge Pharma, LLC
Product
Vancomycin HCl Oral Solution (PF) 125mg / 2.5mL (50 mg/mL), 2.5 mL per syringe, Single Dose Syringe for Oral Use Only, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1348-01
Reason
CGMP Deviations
Classification
Class II
Status
Terminated
Lot
09-2021-10@3 12-09-2021, 09-2021-17@6 12-16-2021, 09-2021-24@8 12-23-2021, 09-2021-30@7 12-29-2021 & 10-2021-13@6 01-11-2022 .
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.