FDA-Drug2022-02-02Class II

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

Edge Pharma, LLC
Hazard

CGMP Deviations

Sold states
nationwide
Affected count
6925 syringes
Manufactured in
856 Hercules Dr, Colchester, VT, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0448-2022

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