Magnesium Chloride
Subpotent drug
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria.
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.
Freskaro refresh & revitalize Magnesium Citrate Saline Laxative Oral Solution Cherry Flavor 10 fl. oz, Manufactured by: Pharma Lobis, 7400 Alumax Dr., Texarkana, TX 75501, NDC 82645-312-10.
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 |
|---|---|---|---|---|
| Magnesium Citrate Freskaro Magnesium Citrate Oral Solution - Cherry NDC 82645-0312 |
MAGNESIUM CITRATE 1.745 g/29.6mL | Liquid Oral |
Pharma Nobis, LLC | OTC |
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
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
Microbial Contamination of Non-Sterile Products - Presence of Acetobacter nitrogenifigens bacteria
Microbial Contamination of Non-Sterile Products - Presence of Acetobacter nitrogenifigens bacteria
MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria.
MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria.
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