FDA (Drugs) recall action 68610
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 impurity test results.
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 5,265 blister packs of Velivet birth control pills nationwide because impurity test results were out of specification.
Teva Pharmaceuticals is recalling 1,104 packs of APRI oral contraceptives because impurity test results were out of specification.
Teva Pharmaceuticals is recalling 1,125 blister packs of Kariva tablets because impurity test results were out of specification.
Teva Pharmaceuticals is recalling Mircette tablets because impurity test results were out of specification. The recall covers 984 blister packs distributed nationwide.