Magnesium Chloride, 6-Hydrate, Crystal, 500G per bottle, Bulk active pharmaceutical ingredient (API), Avantor Performance…
Reason Subpotent drug
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured.
Magnesium Chl 200 mg/mL PF, 100 mL, Medaus Pharmacy 1-800-526-9183
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Subpotent drug
Reason 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.
Reason Failed Disintegration Specifications: above the time expected.
Reason Lack of Assurance of Sterility
Reason Lack of Assurance of Sterility
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