FDA (Drugs) recall action 86663
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 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.
Zydus Pharmaceuticals is recalling 7,908 cartons of Lansoprazole 30 mg tablets because they failed to meet dissolution specifications.
Zydus Pharmaceuticals is recalling 6,840 cartons of Lansoprazole 15 mg tablets because they failed to meet dissolution specifications.