FDA (Drugs) recall action 82581
The FDA (Drugs) publishes a recall like this one as 5 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 5 pages.
Failed Impurities/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.
Lupin Pharmaceuticals is recalling 10,284 bottles of Morphine Sulfate Extended-Release Tablets, 60 mg, due to failed impurities and degradation specifications.
Lupin Pharmaceuticals is recalling 3,444 bottles of Morphine Sulfate Extended-Release Tablets, 100 mg, due to failed impurities and degradation specifications.
Lupin Pharmaceuticals is recalling specific lots of Morphine Sulfate Extended-Release Tablets because they failed impurity and degradation specifications.
Lupin Pharmaceuticals is recalling 17,328 bottles of Morphine Sulfate Extended-Release Tablets because they failed impurity and degradation specifications.
Lupin Pharmaceuticals is recalling specific lots of Morphine Sulfate Extended-Release Tablets because they failed impurity and degradation specifications.