ALUM Concentrate (Aluminum Potassium Sulfate Dodecahydrate in Sterile Water (PF) 30 g/300 ml, IV ...
FDA Recall #D-0394-2022 — Class II — December 6, 2021
Product Description
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
Reason for Recall
Lack of Assurance of Sterility
Recalling Firm
Edge Pharma, LLC — Colchester, VT
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
30 bags
Distribution
nationwide
Code Information
08-2021-25@2 12/08/2021 09-2021-08@1 12/23/2021 10-2021-20@3 02/01/2022
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated