FDA (Drugs) recall action 80553
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.
Failed Tablet/Capsule Specifications: Tablet breakage
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.
Vensun Pharmaceuticals is recalling 3,683 bottles of Potassium Citrate Extended-Release Tablets because they failed specifications due to tablet breakage.
Vensun Pharmaceuticals is recalling 11,652 bottles of Potassium Citrate Extended-Release Tablets because they failed specifications due to tablet breakage.