FDA (Drugs) recall action 97639
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 Dissolution 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.
Ascend Laboratories is recalling several lots of Atorvastatin Calcium Tablets USP 20 mg for failed dissolution specifications.
Ascend Laboratories is recalling 141,984 bottles of Atorvastatin Calcium Tablets USP 10 mg for failed dissolution specifications.
Ascend Laboratories is recalling several lots of Atorvastatin Calcium Tablets USP 40 mg for failed dissolution specifications.
Ascend Laboratories is recalling several lots of Atorvastatin Calcium Tablets USP 80 mg for failed dissolution specifications.