Magnesium Chloride
Subpotent drug
Class I — High risk. Reasonable probability of serious harm or death.
Microbial contamination of non-sterile products.
Cause type: Microbial contamination
Bacteria, mold, yeast or other microorganisms detected in the product. Contamination can occur from water systems, equipment or handling, and can cause infection. All microbial contamination recalls.
meijer, magnesium citrate Saline Laxative, Oral Solution, (1.745 g/fl oz), Lemon Flavor, 10 FL OZ (296 mL), Dist. By Meijer Distribution, Inc. Grand Rapids, MI 49544; NDC 41250-708-38 UPC 7 13733 45945 7
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
Incorrect/Undeclared Excipients.
CGMP Deviations;
CGMP Deviations
CGMP Deviations
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