FDA (Drugs) recall action 91442
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 Specification
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.
Ascend Laboratories is recalling 6,336 bottles of Metoprolol Succinate Extended-Release Tablets, 50 mg, distributed nationwide and in Puerto Rico, due to failed dissolution specification.
Ascend Laboratories recalls 49,632 bottles of Metoprolol Succinate extended-release tablets (25 mg) nationwide and in Puerto Rico due to failure to meet dissolution specifications that could reduce drug effectiveness.
Ascend Laboratories is recalling 2,628 bottles of Metoprolol Succinate Extended-Release Tablets (50 mg) nationwide due to failed dissolution specification. The tablets may not dissolve properly, preventing proper medication absorption.