FDA (Drugs) recall action 64014
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 Impurity/Degradation Specifications due to moisture ingress in individual bottles
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.
Warner Chilcott is recalling 3,155 bottles of Femtrace 0.45 mg tablets due to moisture ingress that failed impurity specifications.
Warner Chilcott is recalling 5,439 bottles of Femtrace 0.9 mg tablets nationwide due to moisture ingress causing failed impurity specifications.