FDA (Drugs) recall action 62350
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.
CGMP Deviations: Eloxatin was manufactured by Ben Venue Laboratories, a contract manufacturer, which was recently inspected by the agency and revealed significant issues in Good Manufacturing Practices.
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.
Sanofi-aventis is recalling 196,355 vials of Eloxatin (oxaliplatin) injection nationwide because the contract manufacturer failed to meet Good Manufacturing Practices.
Sanofi-aventis is recalling Eloxatin (oxaliplatin) injection vials because the contract manufacturer had significant Good Manufacturing Practice issues.