FDA (Drugs) recall action 74068
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:Out of specification result for a known impurity obtained during 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, Inc. is recalling Dicloxacillin Sodium Capsules because testing revealed out-of-specification results for a known impurity.
Sandoz, Inc. is recalling specific lots of Dicloxacillin Sodium Capsules, 500mg, because testing revealed an out-of-specification result for a known impurity.