FDA (Drugs) recall action 66447
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: a recent review of the USP revealed that an incorrect calculation was used to determine the amount of irinotecan to use in formulation which will result in an assay higher than the labeled claim.
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.
West-Ward Pharmaceutical Corp. is recalling Irinotecan Hydrochloride Injection because an incorrect calculation resulted in an assay higher than the labeled claim.
West-Ward Pharmaceutical Corp. is recalling Irinotecan Hydrochloride Injection because a calculation error resulted in drug levels higher than labeled.