FDA (Drugs) recall action 63548
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.
Crystallization: Product is being recalled due to visible particulates identified during a retain sample inspection. Findings have identified the particles as Carboplatin crystals.
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.
Hospira is recalling 31,326 vials of Carboplatin Injection due to visible crystals found during inspection. The product is distributed nationwide and in Puerto Rico.
Hospira Inc. is recalling 23,315 vials of Carboplatin Injection due to visible particulates identified as Carboplatin crystals.