FDA (Drugs) recall action 65077
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.
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 259,050 vials of Furosemide Injection due to a loose crimp on the vial cap that compromises sterility assurance.
Hospira Inc. is recalling 266,900 vials of Sodium Acetate Injection due to loose crimps that may compromise sterility.
Hospira Inc. is recalling QUELICIN (succinylcholine chloride) Injection due to a loose crimp on the vial that compromises sterility assurance.
Hospira Inc. is recalling 114,000 vials of Diazepam Injection due to a loose crimp on the fliptop vial that compromises sterility assurance.