FDA (Drugs) recall action 77106
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 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.
The Harvard Drug Group is recalling 914 cartons of Fluconazole 200 mg tablets because they failed to meet required dissolution specifications.
The Harvard Drug Group is recalling 2,341 cartons of Fluconazole 100 mg tablets because they failed to meet dissolution specifications.