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Recall Observatory FDA recall evidence

Drug 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

D-1066-2013

September 13, 2013

Class II

Product summary

Firm
AmeriSource Bergen
Event
Event 66316
Status
Terminated
Classification
Class II
Quantity
60 vials
Official record key
drug-enforcement:D-1066-2013

Official wording

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

Code information: Lot #s: 7800929, 7800931, Exp 02/15; 7800962, Exp 03/15

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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