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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 66316

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
September 13, 2013
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
AmeriSource Bergen

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

2 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 2

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

D-1065-2013
Recall number
D-1065-2013
Initiated
September 13, 2013
Classification
Class II
Status
Terminated
Recalling firm
AmeriSource Bergen
Quantity
49 vials

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Temperature abuse: Certain vials of Ifosfamide IV products were not refrigerated at certain Amerisource Bergen Drug Corp distribution centers.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

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

Distribution pattern

Nationwide

drug · product 2 of 2

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

D-1066-2013
Recall number
D-1066-2013
Initiated
September 13, 2013
Classification
Class II
Status
Terminated
Recalling firm
AmeriSource Bergen
Quantity
60 vials

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Temperature abuse: Certain vials of Ifosfamide IV products were not refrigerated at certain Amerisource Bergen Drug Corp distribution centers.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

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

Distribution pattern

Nationwide