Why it was recalled
Temperature abuse: Certain vials of Ifosfamide IV products were not refrigerated at certain Amerisource Bergen Drug Corp distribution centers.
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
Lot numbers, UPCs & expiration codes
Lot #s: 7800932, 7800933, exp 02/15
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1065-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 13, 2013
- FDA report date
- Oct 9, 2013
- Quantity
- 49 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- AmeriSource Bergen
Original FDA data
Every field from FDA enforcement report D-1065-2013, exactly as published.
Show all FDA fields
- City
- Chesterbrook
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 66316
- Address
- 1300 Morris Dr
- Code information
- Lot #s: 7800932, 7800933, exp 02/15
- Postal code
- 19087-5559
- Report date
- Oct 9, 2013
- Product type
- Drugs
- Recall number
- D-1065-2013
- Classification
- Class II
- Recalling firm
- AmeriSource Bergen
- Product quantity
- 49 vials
- Termination date
- Oct 1, 2014
- Reason for recall
- Temperature abuse: Certain vials of Ifosfamide IV products were not refrigerated at certain Amerisource Bergen Drug Corp distribution centers.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- Sep 13, 2013
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Sep 27, 2013