FDA (Drugs) recall action 78415
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: high out of specification results for Dexamethasone adduct (related compound).
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.
West-Ward Pharmaceuticals is recalling specific lots of Dexamethasone Sodium Phosphate Injection because of high out-of-specification results for a related compound.
West-Ward Pharmaceuticals is recalling Dexamethasone Sodium Phosphate Injection due to high levels of a related compound impurity.