Drug 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
D-1065-2013
Product summary
- Event
- Event 66316
- Status
- Terminated
- Classification
- Class II
- Quantity
- 49 vials
- Official record key
drug-enforcement:D-1065-2013
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: 7800932, 7800933, exp 02/15
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Temperature abuse: Certain vials of Ifosfamide IV products were not refrigerated at certain Amerisource Bergen Drug Corp distribution centers.