AmeriSource Bergen Recalls Ifosfamide Injection Due to Temperature Abuse
AmeriSource Bergen is recalling 49 vials of Ifosfamide Injection 1g/20mL because they were not properly refrigerated at distribution centers.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this as a Class II recall. Per the rubric, an FDA Class II recall involving a significant risk or potential for serious adverse health consequences is categorized as Severe (Score 4).
Plain-English summary
AmeriSource Bergen is recalling 49 vials of Ifosfamide Injection 1g/20mL, Single dose vial, Rx only, Sterile, For Intravenous Use. The product is distributed by Pfizer Labs, Division of Pfizer Inc., and carries NDC 0069-4495-22. The specific lots affected are 7800932 and 7800933, with an expiration date of 02/15.
The recall was initiated due to temperature abuse. Certain vials of the Ifosfamide IV product were not refrigerated at the required 2-8 degrees Celsius at certain AmeriSource Bergen Drug Corp distribution centers. The distribution pattern for these products is nationwide.
Healthcare providers and patients should stop using the affected vials and contact AmeriSource Bergen for further instructions. The FDA has classified this as a Class II recall.
The recalled product
- 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
- Manufacturer
- AmeriSource Bergen
- Category
- Drug — Injectable Medication
- Affected units
- 49
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot #s: 7800932
- 7800933
- exp 02/15
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by AmeriSource Bergen under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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