Magnesium Chloride, 6-Hydrate, Crystal, 500G per bottle, Bulk active pharmaceutical ingredient (API), Avantor Performance…
Reason Subpotent drug
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Failed Impurities/Degradation Specifications.
Magnesium Citrate Oral Solution Cherry Flavor, 1.745 g per fl oz, packaged in 10 fl. oz ( 296 mL) bottles, Labeled as a) CVS Health, Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895; NDC 6984238038, UPC 050428418321, b) Meijer, Dist. By Meijer Distribution, Inc. Grand Rapids, MI 49544, NDC 4125038038, UPC 708820824294, c) Life Brand, Manufactured for: Shoppers Drug Mark/Pharmaprix Toronto, UPC 057800856405
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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