FDA (Drugs) recall action 66345
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: During stability testing an unknown impurity was found to be above the specification limit at 36 month test interval
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.
Lupin Pharmaceuticals is recalling Quinapril 10 mg tablets because stability testing revealed an unknown impurity above specification limits.
Lupin Pharmaceuticals is recalling Quinapril tablets because an unknown impurity exceeded specification limits during stability testing.