FDA (Drugs) recall action 73101
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.
Labeling: label error on declared strength.
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.
Perrigo is recalling 918 units of Nystatin USP Powder due to a labeling error regarding the declared strength. The product was distributed nationwide.
Perrigo Company PLC is recalling Nystatin, USP Powder for Rx compounding due to a labeling error regarding the declared strength.