FDA (Drugs) recall action 63451
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.
Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles.
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 USA is recalling 240,550 vials of Cyanocobalamin Injection due to potential glass fractures and particles that compromise sterility.
Fresenius Kabi USA is recalling 101,200 vials of Midazolam Hydrochloride Injection due to potential glass fractures and particles that compromise sterility.
Fresenius Kabi USA is recalling 184,550 vials of Ondansetron Injection due to potential glass fractures and particles that compromise sterility.