FDA (Drugs) recall action 97556
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.
Zydus Entecavir Tablets, USP, 0.5 mg, lot E309376, are recalled nationwide after failing impurity and degradation specifications. 4,344 bottles are affected.
Zydus Entecavir Tablets, USP, 1 mg, lot E309377, are recalled nationwide after failing impurity and degradation specifications. 4,440 bottles are affected.