The Recall Desk

FDA (Drugs) recall action 63189

Baxter Healthcare Corp. recalled 5 products on 2012-10-03

The FDA (Drugs) publishes a recall like this one as 5 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 5 pages.

Products
5
Announced
2012-10-03
Critical
0
Units
1,715,141

Why these products were recalled

Chemical Contamination: The IV solutions were packaged in AVIVA containers which may contain trace levels of cumene hydroperoxide (CHP).

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

1–5 of 5

  • SevereFDA (Drugs)··2012-10-03

    Baxter Recalls 5% Dextrose Injection Due to Chemical Contamination

    Baxter Healthcare is recalling 5% Dextrose Injection USP in AVIVA containers due to potential trace levels of cumene hydroperoxide.

    Product
    5% Dextrose Injection USP, packaged in a) 250 mL AVIVA Container, product code 6E0062, NDC 0338-6346-02; b) 500 mL AVIVA Container, product code 6E0063, NDC 0338-6346-03; Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA
    Category
    Distribution
    1 state
  • ModerateFDA (Drugs)··2012-10-03

    Baxter Recalls Lactated Ringer's Injection Due to Chemical Contamination

    Baxter Healthcare is recalling specific lots of Lactated Ringer's Injection USP due to potential trace levels of cumene hydroperoxide.

    Product
    Lactated Ringer's Injection USP, packaged in a) 250 mL AVIVA Container, product code 6E2322B, NDC 0338-6307-02; b) 500 mL AVIVA Container, product code 6E2323, NDC 0338-6307-03; Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA
    Category
    Distribution
    1 state
  • ModerateFDA (Drugs)··2012-10-03

    Baxter Recalls 10% Dextrose Injection Due to Chemical Contamination

    Baxter Healthcare is recalling 2,976 containers of 10% Dextrose Injection USP due to potential trace levels of cumene hydroperoxide.

    Product
    10% Dextrose Injection USP, packaged in a 500 mL AVIVA Container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA; product code 6E0163, NDC 0338-6347-03
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2012-10-03

    Baxter Recalls 5% Dextrose and 0.45% Sodium Chloride Injection Due to Chemical Contamination

    Baxter Healthcare is recalling 5,064 containers of 5% Dextrose and 0.45% Sodium Chloride Injection USP due to potential trace levels of cumene hydroperoxide.

    Product
    5% Dextrose and 0.45% Sodium Chloride Injection USP, packaged in a 500 mL AVIVA Container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA; product code 6E0173, NDC 0338-6308-03
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2012-10-03

    Baxter Recalls 0.9% Sodium Chloride Injection Due to Chemical Contamination

    Baxter Healthcare is recalling 0.9% Sodium Chloride Injection USP in AVIVA containers due to potential trace levels of cumene hydroperoxide.

    Product
    0.9% Sodium Chloride Injection USP, packaged in a) 250 mL AVIVA Container, product code 6E1322, NDC 0338-6304-02; b) 500 mL AVIVA Container, product code 6E1323, NDC 0338-6304-03; Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA
    Category
    Distribution
    1 state