FDA (Drugs) recall action 90257
The FDA (Drugs) publishes a recall like this one as 2 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 2 pages.
Lack of Assurance of Sterility
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
US Specialty Formulations is recalling 781 vials of Ethanol for Injection 95% due to lack of assurance of sterility. The product was distributed nationwide to medical facilities and physician offices.
US Specialty Formulations is recalling B-Complex plus Chromic Chloride injectable vials due to lack of assurance of sterility. The product was distributed to medical facilities and physician offices nationwide.