FDA (Drugs) recall action 64643
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 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 Errin (norethindrone) tablets because an impurity called N-Butyl-Benzene Sulfonamide was detected during testing.
Teva Pharmaceuticals is recalling Camila (norethindrone) tablets because an impurity called N-Butyl-Benzene Sulfonamide was detected during testing.