FDA (Drugs) recall action 80254
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.
Superpotent Drug: High out of specification assay value results for potency.
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.
Ingenus Pharmaceuticals is recalling specific lots of Irinotecan Hydrochloride Injection because they had high out-of-specification assay values for potency.
Ingenus Pharmaceuticals is recalling Irinotecan Hydrochloride Injection because of high out-of-specification assay values for potency.