FDA (Drugs) recall action 89803
The FDA (Drugs) publishes a recall like this one as 4 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 4 pages.
Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
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.
Tetracaine 1% Injectable is being recalled due to sterility assurance failures caused by manufacturing deviations that may compromise product sterility.
Vitae Enim Vitae Scientific is recalling Phenobarbital Sodium Injection nationally due to deviations from manufacturing practices that compromise sterility assurance on this injectable drug.
Vitae Enim Vitae Scientific, Inc. is recalling Phenobarbital Sodium Injection nationwide due to deviations from Current Good Manufacturing Practices (CGMP) that raise concerns about product sterility.
Vitae Enim Vitae Scientific, Inc. is recalling papaverine hydrochloride injection nationwide due to manufacturing deviations that compromise sterility assurance in this intravenous drug product.