FDA (Drugs) recall action 97866
The FDA (Drugs) publishes a recall like this one as 4 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 4 pages.
Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C.
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.
Endo USA is recalling 1,866 cartons of Everolimus tablets 7.5 mg after results came back out of specification for impurity IP-C.
Endo USA is recalling 6,655 cartons of Everolimus tablets 5 mg after results came back out of specification for impurity IP-C.
Endo USA is recalling 2,035 cartons of Everolimus tablets 2.5 mg after results came back out of specification for impurity IP-C.
Endo USA is recalling 935 cartons of Everolimus tablets 10 mg after results came back out of specification for impurity IP-C.