FDA (Drugs) recall action 98391
The FDA (Drugs) publishes a recall like this one as 5 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 5 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.
Fresenius Kabi Compounding is recalling vancomycin HCl 2 grams in 500 mL sodium chloride injection over a lack of assurance of sterility.
Fresenius Kabi Compounding is recalling 1,057 bags of acyclovir sodium 200 mg in 100 mL sodium chloride injection over a lack of assurance of sterility.
Fresenius Kabi Compounding is recalling 1,410 bags of Ketamine HCl injection over a lack of assurance of sterility.
Fresenius Kabi Compounding is recalling 1,578 bags of Vancomycin HCl injection over a lack of assurance of sterility.
Fresenius Kabi Compounding is recalling 10,548 bags of thiamine HCl 500 mg in sodium chloride injection over a lack of assurance of sterility.