The Recall Desk

FDA (Drugs) recall action 73811

Fresenius Kabi USA, LLC recalled 2 products on 2016-06-01

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
2016-06-01
Critical
0
Units
395,430

Why these products were recalled

Failed Impuities/Degradation Specifications

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)··2016-06-01

    Fresenius Kabi Recalls Octreotide Acetate Injection Due to Impurities

    Fresenius Kabi USA is recalling Octreotide Acetate Injection vials because they failed impurities and degradation specifications.

    Product
    OCTREOTIDE ACETATE INJECTION, 50 mcg (base)/mL (0.05 mg/mL), 1 mL Single Dose Vial, Rx only, Manufactured by Fresenius Kabi USA, LLC, Schaumburg, IL 60173, NDC 63323-365-04
    Category
    Distribution
    1 state
  • SevereFDA (Drugs)··2016-06-01

    Fresenius Kabi Recalls Octreotide Acetate Injection Due to Impurities

    Fresenius Kabi is recalling specific lots of Octreotide Acetate Injection because they failed impurities and degradation specifications.

    Product
    OCTREOTIDE ACETATE INJECTION, 50 mcg (base)/mL (0.05 mg/mL), 1 mL Single Dose Vial, Rx only, Manufactured by Fresenius Kabi USA, LLC, Schaumburg, IL 60173, NDC 63323-365-01.
    Category
    Distribution
    1 state