FDA (Drugs) recall action 63926
The FDA (Drugs) publishes a recall like this one as 3 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 3 pages.
Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolution over the product shelf life.
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.
Amedra Pharmaceuticals is recalling 1,176 bottles of Dextroamphetamine Sulfate Extended Release Capsules because they may not meet dissolution specifications.
Amedra Pharmaceuticals is recalling 10,968 bottles of Dextroamphetamine Sulfate Extended Release Capsules because they may not meet dissolution specifications over the product shelf life.
Amedra Pharmaceuticals is recalling 12,948 bottles of Dextroamphetamine Sulfate Extended Release Capsules because they may not meet dissolution specifications over their shelf life.