FDA (Drugs) recall action 68152
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 Particular Matter: Potential glass delamination and consistent with glass particulates observed in sample vials.
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, LLC is recalling Fosphenytoin Sodium Injection vials due to potential glass delamination and particulates.
Fresenius Kabi USA, LLC is recalling 728,880 vials of Fosphenytoin Sodium Injection due to potential glass delamination and particulates.