MAGnesium 2gm in NS 2 gm recalled over sterility concerns
- Recall date
- June 12, 2018
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Avella of Deer Valley, Inc. Store 38 recalls MAGnesium 2gm in NS 100 mL (MAGnesium SULfate (USP) 2 gm, 0.9% Sodium Chloride (USP) 100 mL). Volume: 104 mL. Single do…
- Recall number
- D-0952-2018
- FDA classification
- Class II
- Brand / firm
- Avella of Deer Valley, Inc. Store 38
- Sold / distributed
- Nationwide in the USA
Why it was recalled
Lack of Assurance of Sterility: Potential leakage of bags.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
MAGnesium 2gm in NS 100 mL (MAGnesium SULfate (USP) 2 gm, 0.9% Sodium Chloride (USP) 100 mL). Volume: 104 mL. Single dose bag. For: Desert Regional Med Ctr By: Avella of Houston, 9256 Kirby Dr., Houston, TX 77054. NDC: 42852-907-10
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