FDA (Drugs) recall action 85504
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.
Presence of Particulate Matter - found in reserve sample vials at the firm.
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.
Fresenius Kabi is recalling specific lots of Ketorolac Tromethamine Injection because particulate matter was found in reserve sample vials.
Fresenius Kabi is recalling specific lots of Ketorolac Tromethamine Injection because particulate matter was found in reserve sample vials.