FDA (Drugs) recall action 80653
The FDA (Drugs) publishes a recall like this one as 3 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 3 pages.
Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
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.
Baxter Healthcare is recalling 711,216 bags of Levofloxacin Injection in 5% Dextrose because the solution concentration was higher than specified.
Baxter Healthcare is recalling 191,256 bags of Levofloxacin Injection in 5% Dextrose due to high out-of-specification potency results.
Baxter Healthcare is recalling specific lots of Levofloxacin Injection in 5% Dextrose because the solution concentration was higher than specified.