FDA (Drugs) recall action 74187
The FDA (Drugs) publishes a recall like this one as 51 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 51 pages.
Lack of Assurance of Sterility: FDA inspection identified GMP violations potentially impacting product quality and 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.
Well Care Compounding Pharmacy is recalling TRI-MIX # 5 vials because FDA inspections found GMP violations that may affect sterility.