Agency classClass IIOur severity:Severe FDA (Drugs)·D-1066-2013·Announced 2013-10-09

AmeriSource Bergen Recalls Ifosfamide Injection Due to Temperature Abuse

AmeriSource Bergen is recalling specific lots of Ifosfamide Injection because they were not refrigerated at certain distribution centers.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or structural defects are rated Severe (4). While no specific injuries are reported in the text, the failure to maintain required cold chain for a sterile IV chemotherapy agent represents a significant risk of product degradation and potential harm, fitting the Severe criteria for Class II drug recalls with potential for serious adverse consequences.

Plain-English summary

AmeriSource Bergen is recalling 60 vials of Ifosfamide Injection 3g/60 mL, Single dose vial, Rx only, Sterile, For Intravenous Use. The product is distributed by Pfizer Labs, Division of Pfizer Inc., and carries NDC 0069-4496-22.

The recall was initiated due to temperature abuse. Certain vials of the Ifosfamide IV products were not refrigerated at certain Amerisource Bergen Drug Corp distribution centers. The affected lots are 7800929 and 7800931 (Exp 02/15) and 7800962 (Exp 03/15). The distribution pattern is nationwide.

Healthcare providers and patients should stop using the affected lots and contact AmeriSource Bergen for further instructions. The FDA has classified this recall as Class II.

The recalled product

Product: 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
Manufacturer: AmeriSource Bergen
Category: Drug — Antineoplastic
Hazard: temperature-abuse
product-degradation
Affected units: 60

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 (5)

Lot #s: 7800929
7800931
Exp 02/15
7800962
Exp 03/15

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 →

Same manufacturer · AmeriSource Bergen

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Severe
AmeriSource Bergen Recalls Ifosfamide Injection Due to Temperature Abuse
FDA (Drugs) · 2013-10-09

Same hazard · temperature abuse