D-1065-2013 Class II Terminated
FDA drug recall D-1065-2013 was initiated by AmeriSource Bergen on September 13, 2013 and is designated Class II. Reason for recall: Temperature abuse: Certain vials of Ifosfamide IV products were not refrigerated at certain Amerisource Bergen Drug Corp distribution centers. The recall status is terminated (terminated October 1, 2014). Affected quantity: 49 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- October 9, 2013
- Initiation Date
- September 13, 2013
- Termination Date
- October 1, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 49 vials
Product Description
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
Reason for Recall
Temperature abuse: Certain vials of Ifosfamide IV products were not refrigerated at certain Amerisource Bergen Drug Corp distribution centers.
Distribution Pattern
Nationwide
Code Information
Lot #s: 7800932, 7800933, exp 02/15