The Recall Desk

FDA (Drugs) recall action 67317

Hospira Inc. recalled 2 products on 2014-02-05

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.

Products
2
Announced
2014-02-05
Critical
0
Units
43,038

Why these products were recalled

Lack of Assurance of Sterility; potential leakage from administrative port.

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.

States named across these recalls

1–2 of 2

  • SevereFDA (Drugs)··2014-02-05

    Hospira Recalls Aminosyn 3.5% Bags Due to Sterility Concerns

    Hospira Inc. is recalling 15,258 bags of Aminosyn 3.5% M Sulfite-Free due to a lack of assurance of sterility and potential leakage from the administrative port.

    Product
    Aminosyn 3.5% M Sulfite-Free, A Crystalline Amino Acid Solution* with Maintenance Electrolytes with Phosphorus, 1000 mL bag, Rx only. Hospira Inc, Lake Forest, IL, 60045. NDC: 0409-4196-05
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2014-02-05

    Hospira Recalls Heparin Sodium Bags Due to Sterility Concerns

    Hospira is recalling 27,780 bags of Heparin Sodium 2000 USP Units per 1000 mL due to a lack of assurance of sterility and potential leakage from the administrative port.

    Product
    HEPARIN SODIUM (HEPARIN SODIUM)
    Category
    Distribution
    1 state