FDAFDA · Food and drugs·Recall number D-0394-2022
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
Published February 2, 2022 · Recall initiated: December 6, 2021
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility
What to do
Voluntary: Firm initiated · Press Release
Recall details
- Manufacturer
- Edge Pharma, LLC
- Distributor
- nationwide
- Lot
- 08-2021-25@2 12/08/2021 09-2021-08@1 12/23/2021 10-2021-20@3 02/01/2022
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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