FDA (Drugs) recall action 97160
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
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.
AvKARE is recalling Pitavastatin 2 mg tablets nationwide due to failed impurity and degradation specifications. The affected lots do not meet quality standards for chemical purity.
Pitavastatin Tablets 1 mg from AvKARE are being recalled because they failed impurity and degradation specifications. 1,560 bottles are affected.