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.
Superpotent Drug: high out-of-specification result for magnesium.
Gaviscon (Alumina & Magnesium Trisilicate) Regular Strength Original Flavor Chewable Tablets, 80 mg & 14.2 mg, 100-count bottles, Distributed by: GlaxoSmithKline Consumer Healthcare, L.P., Moon Twp, PA 15108, UPC 3 0088-1175-47 8.
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
Tell us which medications you take. If the FDA recalls one, we email you - in plain English, with what to do. Free.