FDA (Drugs) recall action 74466
The FDA (Drugs) publishes a recall like this one as 88 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 88 pages.
Lack of Assurance of Sterility
The agency’s own wording, quoted from the enforcement report.
Medaus, Inc. is recalling EDTA Disodium 15% vials because the company cannot ensure the product is sterile. The recall covers vials distributed in the U.S., Japan, and New Zealand.
Medaus, Inc. is recalling Lidocaine 2% (PF) in NaCl 10mL vials due to a lack of assurance of sterility. The product was distributed in the U.S., Japan, and New Zealand.
Medaus, Inc. is recalling specific lots of Zinc Chloride vials because the company cannot guarantee the product is sterile.
Medaus, Inc. is recalling specific lots of L-Carnitine 250mg/mL vials because the company cannot guarantee the product is sterile.
Medaus, Inc. is recalling specific lots of Hydrogen Peroxide 3% vials because the company cannot ensure the product is sterile.
Medaus, Inc. is recalling specific lots of Germanium Seso 100mg/mL vials because the FDA determined there is a lack of assurance of sterility.
Medaus, Inc. is recalling specific lots of Niacinamide 100 mg/mL vials because the company cannot guarantee the product's sterility.
Medaus, Inc. is recalling Tryptophan 10mg/mL vials because the company cannot ensure the product is sterile. The recall affects 10mL and 50mL vials distributed in the U.S., Japan, and New Zealand.
Medaus, Inc. is recalling specific lots of Methyl B12 and Pyridoxine vials because the company cannot guarantee the product is sterile.
Medaus, Inc. is recalling M.I.C B-Complex vials distributed in the U.S., Japan, and New Zealand due to a lack of assurance of sterility.
Medaus, Inc. is recalling M.I.C 25/50/50 vials because the company cannot guarantee the product is sterile.
Medaus, Inc. is recalling Lipo #4 vials because the FDA cannot assure the product is sterile. The recall affects vials distributed in the U.S., Japan, and New Zealand.
Medaus, Inc. is recalling Molybdenum 250mcg/mL vials because the company cannot ensure the product is sterile. The recall covers distribution in the U.S., Japan, and New Zealand.