FDA (Drugs) recall action 66172
The FDA (Drugs) publishes a recall like this one as 8 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 8 pages.
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.
The agency’s own wording, quoted from the enforcement report.
Medaus, Inc. is recalling Taurine 50 mg/mL PF, 100 mL, due to laboratory results indicating microbial contamination and concerns about the reliability of sterility testing.
Medaus, Inc. is recalling Magnesium Chloride 200 mg/mL PF, 100 mL vials due to laboratory results indicating microbial contamination and concerns about the reliability of sterility testing.
Medaus, Inc. is recalling specific lots of Lipo-Injection w/ Lidocaine because laboratory results indicate microbial contamination and sterility cannot be assured.
Medaus, Inc. is recalling L-Glutathione 200 mg/mL PF, 100 mL, due to laboratory results indicating microbial contamination and concerns about the reliability of sterility testing.
Medaus, Inc. is recalling 15,500 mL of Sodium Ascorbate 500 mg/mL injection due to laboratory results indicating microbial contamination and concerns about the reliability of sterility testing.
Medaus, Inc. is recalling Testosterone Cyp 200 mg/mL injections because laboratory results indicate microbial contamination and the sterility of the product cannot be assured.
Medaus, Inc. is recalling Pyridoxine HCL 100 mg/mL due to laboratory results indicating microbial contamination and concerns about the reliability of sterility testing.
Medaus, Inc. is recalling NA Ascorbate 500 mg/mL injection due to laboratory results indicating microbial contamination and concerns about the reliability of sterility testing.