FDA (Drugs) recall action 66822
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.
Marketed without an Approved NDA/ANDA: This recall is being initiated because of changes to the dissolution profile in distributed lots resulting from a manufacturing site change. There is currently no approved application supporting the alternate manufacturing site.
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.
Greenstone LLC is recalling 2,796 bottles of Spironolactone 25 mg tablets because they were manufactured at an unapproved site, altering the dissolution profile.
Greenstone LLC is recalling 4,848 bottles of Spironolactone 50 mg tablets because the manufacturing site change resulted in an unapproved dissolution profile.