FDA (Drugs) recall action 80326
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.
Subpotency: lower than expected potency result was obtained at the 18 month stability time point.
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.
Validus Pharmaceuticals is recalling 696 bottles of Rocaltrol (calcitriol) Oral Solution because testing showed lower than expected potency.
Validus Pharmaceuticals is recalling 7,864 bottles of Calcitriol Oral Solution because testing showed lower than expected potency at the 18-month stability time point.