FDA (Drugs) recall action 63160
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.
Impurities/Degradation Products: An out of specification result for a known impurity of the product occurred during 12 month stability testing.
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.
Sandoz Incorporated is recalling Pramipexole Dihydrochloride Tablets, 0.25 mg, because an out-of-specification result for a known impurity occurred during stability testing.
Sandoz Incorporated is recalling specific lots of Pramipexole Dihydrochloride Tablets because stability testing revealed an out-of-specification impurity.