Status
Terminated
Drug Enforcement D-1065-2013
Temperature abuse: Certain vials of Ifosfamide IV products were not refrigerated at certain Amerisource Bergen Drug Corp distribution centers.
Classification
Class II
Report Date
October 9, 2013
Termination Date
October 1, 2014
Product Information
- 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
- Product quantity
- 49 vials
- Reason for recall
- Temperature abuse: Certain vials of Ifosfamide IV products were not refrigerated at certain Amerisource Bergen Drug Corp distribution centers.
- Recall initiation reason
- —
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- AmeriSource Bergen
- Address
-
1300 Morris Dr
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-1065-2013
- Event ID
- 66316
- Recall initiation date
- September 13, 2013
- Center classification date
- September 27, 2013
- Code info
- Lot #s: 7800932, 7800933, exp 02/15
- More code info
- —