FDA (Drugs) recall action 79065
The FDA (Drugs) publishes a recall like this one as 3 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 3 pages.
Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability
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.
Dr. Reddy's Laboratories is recalling Atorvastatin Calcium 10 mg tablets because stability testing showed out-of-specification results for total degradation impurities.
Dr. Reddy's is recalling 12,579 bottles of Atorvastatin Calcium 40 mg tablets because they failed impurity specifications during stability testing.
Dr. Reddy's Laboratories is recalling Atorvastatin Calcium 20 mg tablets because stability testing revealed out-of-specification total degradation impurities.