The Recall Desk

FDA (Drugs) recall action 63765

Bracco Diagnostic Inc recalled 2 products on 2013-02-13

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
2013-02-13
Critical
1
Units
—

Why these products were recalled

Presence of Particulate Matter; fibers identified as cellulose and polyvinyl

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

1–2 of 2

  • SevereFDA (Drugs)··2013-02-13

    Bracco Recalls Isovue-300 Injection Syringes Due to Particulate Matter

    Bracco Diagnostic Inc. is recalling specific lots of Isovue-300 Injection syringes because they contain particulate matter identified as cellulose and polyvinyl fibers.

    Product
    Isovue -300 (Iopamidol) Injection 61% Prefilled, 10 x 100 mL Power Injector Syringe, Rx Only, Manufactured for Bracco Diagnostics Inc., Princeton, NJ 08543 by Nycomed GmbH 78224 Singen (Germany); NDC 0270-1315-67.
    Category
    Distribution
    0 states
  • CriticalFDA (Drugs)··2013-02-13

    Bracco Recalls Isovue-370 Injection Syringes Due to Particulate Matter

    Bracco Diagnostic Inc. is recalling specific lots of Isovue-370 injection syringes because they contain particulate matter, including cellulose and polyvinyl fibers.

    Product
    Isovue -370 (Iopamidol) Injection 76%, Prefilled 10 x 75 mL (NDC 0270-1316-66), 10 x 100 mL (NDC 0270-1316-67), 10 x 125 mL (NDC 0270-1316-68) Power Injector Syringe, Rx Only, Manufactured for Bracco Diagnostics Inc., Princeton, NJ 08543 by Nycomed GmbH 78224 Singen (Germany).
    Category
    Distribution
    0 states