Magnesium Chloride
Subpotent drug
Class I — High risk. Reasonable probability of serious harm or death.
Subpotent
Cause type: Wrong potency / content
Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.
MAGnesium 2 gm in NS 100 mL Magnesium SULfate (USP) 0.9% Sodium Chloride (USP) in 100 mL Sterile single dose bag, Rx only, Avella of Houston 9265 Katy Dr., Houston, TX ---NDC 42852-907-10
Compare with the code on your package — it is the most precise check available.
Drug: Magnesium
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Subpotent drug
Product mix up: a foil pouch labeled "Magnesium Sulfate in Water for Injection, 4 g/100 mL" actually contained an IV bag of Tranexamic Acid instead.
Failed Disintegration Specifications: above the time expected.
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Sub-potency
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
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