ALUM Concentrate IV Bags Recalled for Lack of Sterility Assurance
Edge Pharma, LLC is recalling ALUM Concentrate (Aluminum Potassium Sulfate Dodecahydrate) IV bags nationwide due to lack of assurance of sterility. The affected product is a prescription intravenous medication supplied in 300 ml bags.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is a FDA Class II recall of a sterile injectable pharmaceutical product with a lack of sterility assurance, which creates significant risk of infection or harm if administered. Class II recalls of intravenous medications affecting sterility meet the Severe threshold.
Plain-English summary
Edge Pharma, LLC is recalling ALUM Concentrate (Aluminum Potassium Sulfate Dodecahydrate in Sterile Water) intravenous bags due to a lack of assurance of sterility. The product is a prescription medication supplied in 30 g/300 ml IV bags with NDC 05446-0637-03.
The recall affects 30 bags distributed nationwide. Affected lots include 08-2021-25@2 (dated 12/08/2021), 09-2021-08@1 (dated 12/23/2021), and 10-2021-20@3 (dated 02/01/2022).
Healthcare providers and patients who have received or are in possession of affected lots should discontinue use and contact Edge Pharma, LLC immediately. For additional information, consumers and providers should contact the recalling firm.
The recalled product
- Product
- 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
- Manufacturer
- Edge Pharma, LLC
- Category
- Drug — Injectable / Intravenous
- Hazard
- lack-of-sterility
- contamination-risk
- injection-safety
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 08-2021-25@2 12/08/2021 09-2021-08@1 12/23/2021 10-2021-20@3 02/01/2022
Distribution
Distributed nationwide across the United States.
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