FDA-Drug2022-02-02Class II

ALUM Concentrate (Aluminum Potassium Sulfate Dodecahydrate in Sterile Water (PF) 30 g/300 ml, IV bag, Rx Only, Edge Pharma, LLC, 856 Hercules Dr, Colchester, VT 05446, NDC 05446-0637-03

Edge Pharma, LLC
Hazard

Lack of Assurance of Sterility

Sold states
nationwide
Affected count
30 bags
Manufactured in
856 Hercules Dr, Colchester, VT, United States
Products
ALUM Concentrate (Aluminum Potassium Sulfate Dodecahydrate in Sterile Water (PF) 30 g/300 ml, IV bag, Rx Only, Edge Pharma, LLC, 856 Hercules Dr, Colchester, VT 05446, NDC 05446-0637-03

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0394-2022

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