The Recall Desk

FDA (Drugs) recall action 66316

AmeriSource Bergen recalled 2 products on 2013-10-09

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
2013-10-09
Critical
0
Units
109

Why these products were recalled

Temperature abuse: Certain vials of Ifosfamide IV products were not refrigerated at certain Amerisource Bergen Drug Corp distribution centers.

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.

1–2 of 2

  • SevereFDA (Drugs)··2013-10-09

    AmeriSource Bergen Recalls Ifosfamide Injection Due to Temperature Abuse

    AmeriSource Bergen is recalling 49 vials of Ifosfamide Injection 1g/20mL because they were not properly refrigerated at distribution centers.

    Product
    Ifosfamide Injection 1g/20mL, Single dose vial, Rx only, Sterile, For Intravenous Use, Refrigerate at 2-8 degrees celcius, Distributed by Pfizer Labs, Division of Pfizer Inc., New York, NY 10017, NDC 0069-4495-22
    Category
    Distribution
    0 states
  • SevereFDA (Drugs)··2013-10-09

    AmeriSource Bergen Recalls Ifosfamide Injection Due to Temperature Abuse

    AmeriSource Bergen is recalling specific lots of Ifosfamide Injection because they were not refrigerated at certain distribution centers.

    Product
    Ifosfamide Injection 3g/60 mL, Single dose vial, Rx only, Sterile, For Intravenous Use, Refrigerate at 2-8 degrees celcius, Distributed by Pfizer Labs, Division of Pfizer Inc., New York, NY 10017, NDC 0069-4496-22
    Category
    Distribution
    0 states