FDA (Drugs) recall action 85831
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.
Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use.
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.
Hikma Pharmaceuticals is recalling 82,426 vials of Irinotecan Hydrochloride Injection due to a crimp defect in the flip-cap.
Hikma Pharmaceuticals is recalling 17,998 vials of Irinotecan Hydrochloride Injection due to a crimp defect in the flip-cap.