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.
Rexall, Magnesium Citrate Saline Laxative, Oral Solution, (1.745 g/fl oz), Lemon Flavor, 10 FL OZ (296 mL), Distributed By Dolgencorp. LLC 100 Mission Ridge, Goodlettsville, TN 37072 or Distributed By Old East Main Co. 100 Mission Ridge Goodlettsville, TN 37072; NDC 55910-183-38, UPC 0 72785 13418 8
Compare with the code on your package — it is the most precise check available.
Drug: Magnesium
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| citroma Magnesium Citrate NDC 55910-0183 |
1.745 g/29.6mL | Liquid Oral |
Old East Main Co. | OTC |
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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