FDA (Drugs) recall action 73118
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.
Presence of Particulate Matter: identified as cardboard.
Presence of Particulate Matter: identified as a cloth fiber.
Lack of Assurance of Sterility: potential for leaking containers which lacks the 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.
Baxter Healthcare is recalling 273,520 bags of 0.9% Sodium Chloride Injection USP due to the presence of cardboard particulate matter.
Baxter Healthcare Corp. is recalling 334,560 bags of Metronidazole Injection USP due to the presence of a cloth fiber. The product was distributed nationwide and in Puerto Rico.
Baxter Healthcare is recalling 282,080 bags of 0.9% Sodium Chloride Injection USP due to a lack of assurance of sterility caused by potential container leaks.
Baxter Healthcare is recalling 7,436 bags of Clinimix E injection due to the presence of dried skin particulate matter. The product was distributed nationwide and in Puerto Rico.