AmeriSource Bergen: Temperature abuse: Certain vials of Ifosfamide IV products were not refrigerated at certain Amerisource Bergen Drug Corp distribution centers.

Agency Publication Date: September 27, 2013

Affected Products

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

Lot #s: 7800932, 7800933, exp 02/15

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

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

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 66316

Status: Resolved

Manufacturer: AmeriSource Bergen

Manufactured In: United States

Units Affected: 2 products (49 vials; 60 vials)

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Sources: FDA iRES · Raw API Response

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