FDA (Drugs) recall action 97076
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 Impurities/Degradation Specifications.
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 Pitavastatin 2 mg tablets manufactured by Orient Pharma due to failed impurities and degradation specifications.
Pitavastatin Tablets 1 mg manufactured by Orient Pharma for Teva Pharmaceuticals are being recalled because they failed impurities and degradation specifications. 20,618 bottles affected.