ALUM Concentrate / recalled over sterility concerns
- Recall date
- December 6, 2021
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Edge Pharma, LLC recalls ALUM Concentrate (Aluminum Potassium Sulfate Dodecahydrate in Sterile Water (PF) 30 g/300 ml, IV bag, Rx Only, Edge Pha…
- Recall number
- D-0394-2022
- FDA classification
- Class II
- Brand / firm
- Edge Pharma, LLC
- Sold / distributed
- nationwide
Why it was recalled
Lack of Assurance of Sterility
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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
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