FDA (Drugs) recall action 64644
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 Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
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.
Teva Pharmaceuticals is recalling specific lots of Jolessa birth control tablets because an impurity was detected during testing.
Teva Pharmaceuticals is recalling Junel oral contraceptives because an impurity called N-Butyl-Benzene Sulfonamide was detected during testing.
Teva Pharmaceuticals is recalling Lessina oral contraceptives because an impurity was detected during testing. The FDA classifies this as a Class III recall.
Teva Pharmaceuticals is recalling Balziva (norethindrone and ethinyl estradiol) tablets because an impurity was detected during testing.