FDA (Drugs) recall action 64720
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.
Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial
Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.
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.
Hospira Inc. is recalling 26,100 vials of Morphine Sulfate Injection because a loose crimp on the vial cap may compromise sterility.
Hospira Inc. is recalling 172,350 vials of Diazepam Injection due to a loose crimp on the fliptop vial that compromises sterility assurance.