The Recall Desk

FDA (Drugs) recall action 77533

Hospira a Pfizer Company recalled 4 products on 2017-08-09

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.

Products
4
Announced
2017-08-09
Critical
0
Units
—

Why these products were recalled

Lack of Sterility Assurance

The agency’s own wording, quoted from the enforcement report.

States named across these recalls

1–4 of 4

  • SevereFDA (Drugs)··2017-08-09

    Hospira Recalls Sodium Bicarbonate Additive Solution Due to Sterility Concerns

    Hospira is recalling specific lots of Sodium Bicarbonate 4% Additive Solution because they may lack sterility assurance. The recall covers 21.4 million vials distributed in the U.S. and internationally.

    Product
    Neut Sodium Bicarbonate 4% (2.4 mEq) Additive Solution 5 mL , a.) Single-dose vial (NDC 0409-6609-02), b.) 25 vial carton (NDC 0409-6609-25), Rx Only, Mfd by Hospira, INC, Lake Forest, IL 60045 USA
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2017-08-09

    Hospira Recalls Quelicin Injection Due to Lack of Sterility Assurance

    Hospira is recalling Quelicin (succinylcholine chloride) injection vials because they may lack sterility assurance. The recall covers 15,034,600 vials distributed in the U.S. and internationally.

    Product
    QUELICIN (SUCCINYLCHOLINE CHLORIDE)
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2017-08-09

    Hospira Recalls Potassium Phosphates Injection Due to Sterility Concerns

    Hospira is recalling 20.3 million vials of Potassium Phosphates Injection because of a lack of sterility assurance. The product was distributed in the U.S. and several international locations.

    Product
    Potassium Phosphates Inj., USP, 45 mM (3 mM P/mL) Also contains: 66 mEq K+ (4.4 mEq/mL) 15 mL, Single-dose, Caution: Must Be Diluted, Rx Only, Mfd by Hospira, Inc. Lake Forest, IL 60045 USA, NDC: 0409-7295-01
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2017-08-09

    Hospira Recalls 8.4% Sodium Bicarbonate Injection Due to Sterility Concerns

    Hospira is recalling 8.4% Sodium Bicarbonate Injection vials because they may lack sterility assurance. The recall covers 91,483,150 vials distributed in the U.S. and internationally.

    Product
    8.4% Sodium Bicarbonate Inj., USP 50 mL Single-dose, 50 mEq (1 mEq/mL) 4.2 grams (84 mg/mL), Rx Only, Mfd by Hospira, INC, Lake Forest, IL 60045 USA, NDC: 0409-6625-02
    Category
    Distribution
    1 state