CLASS II Drug recall · Reported 9 Oct 2013 · FDA Enforcement Report
Ifosfamide Injection, Single dose vial recalled by AmeriSource Bergen
AmeriSource Bergen is recalling Ifosfamide Injection, Single dose vial, distributed nationwide in the US. The recall was initiated on 13 Sep 2013 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1066-2013
- FDA event ID
- 66316
- Recalling firm
- AmeriSource Bergen, Chesterbrook, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 Sep 2013
- FDA classified
- 27 Sep 2013
- Reported
- 9 Oct 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Temperature Abuse
- Drug class
- Injectable & IV Drugs
Timeline
| 13 Sep 2013 | Recall initiated by company | |
| 27 Sep 2013 | Classified by FDA | +14 days |
| 9 Oct 2013 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Temperature abuse: Certain vials of Ifosfamide IV products were not refrigerated at certain Amerisource Bergen Drug Corp distribution centers.
Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.
Product as listed by the FDA
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
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Temperature abuse: Certain vials of Ifosfamide IV products were not refrigerated at certain Amerisource Bergen Drug Corp distribution centers.
Which lots are affected?
Lot #s: 7800929, 7800931, Exp 02/15; 7800962, Exp 03/15
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 66316| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Ifosfamide Injection, Single dose vial recalled by AmeriSource Bergen | AmeriSource Bergen | Temperature Abuse | Nationwide |
More recalls from AmeriSource Bergen
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Ifosfamide Injection, Single dose vial recalled by AmeriSource Bergen | AmeriSource Bergen | Temperature Abuse | Nationwide |
Other Ifosfamide recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Ifosfamide 9200 MG / Ns Ivpb With Mesna 9200 MG recalled | Infusion Options | Sterility | NY |
| Drug | CLASS II | Ifosfamide Injection, Single dose vial recalled by AmeriSource Bergen | AmeriSource Bergen | Temperature Abuse | Nationwide |