FDA (Drugs) recall action 38329
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.
Subpotent (Single Ingredient Drug): Distribution of product that did not meet specifications.
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.
Apotex Corp. is recalling specific lots of Leflunomide 10 mg tablets because they did not meet potency specifications.
Apotex Corp. is recalling 31 bottles of Leflunomide 20 mg tablets because the product did not meet specifications. The recall is nationwide.