FDA (Drugs) recall action 62459
The FDA (Drugs) publishes a recall like this one as 4 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 4 pages.
The affected lots of Carboplatin Injection, Cytarabine Injection, Methotrexate Injection, USP, and Paclitaxel Injection are being recalled due to visible particles embedded in the glass located at the neck of the vial. There may be the potential for product to come into contact with the embedded particles and the particles may become dislodged into the solution.
The affected lots of Carboplatin Injection, Cytarabine Injection, Methotrexate Injection, USP, and Paclitaxel Injection are beig recalled due to visible particles embedded in the glass located at the neck of the vial. There may be the potential for product to come into contact with the embedded particles and the particles may become dislodged into the solution.
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 Inc. is recalling Paclitaxel Injection vials because visible particles are embedded in the glass at the neck. The particles may dislodge into the solution.
Hospira Inc. is recalling Carboplatin Injection vials because visible particles are embedded in the glass neck, posing a risk of dislodging into the solution.
Hospira Inc. is recalling Methotrexate Injection vials because visible particles embedded in the glass neck may dislodge into the solution.
Hospira is recalling 210 vials of Cytarabine Injection because visible particles embedded in the glass neck may dislodge into the solution.