FDA (Drugs) recall action 79419
The FDA (Drugs) publishes a recall like this one as 3 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 3 pages.
Failed Impurities/Degradation Specifications: High out of specification results for an impurity.
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.
Sagent Pharmaceuticals is recalling 176,410 vials of methylprednisolone sodium succinate injection due to high impurity levels.
Sagent Pharmaceuticals is recalling 205,370 vials of methylprednisolone sodium succinate for injection due to high impurity levels.
Sagent Pharmaceuticals is recalling methylprednisolone sodium succinate for injection vials due to high impurity levels. The affected lots were distributed nationwide.