FDA (Drugs) recall action 98656
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 particulate matter
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.
GE Healthcare is recalling Omnipaque (iohexol) Injection, 350 mg/mL, over the presence of particulate matter. The action covers 306,810 vials distributed nationwide.
GE Healthcare is recalling Omnipaque (iohexol) Injection, 300 mg/mL, over the presence of particulate matter. The action covers 866,570 vials distributed nationwide.