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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 62350

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

Open FDA event record

Event summary

Timeline bucket
February 06, 2012
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
sanofi-aventis US, Inc.

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

Eloxatin (OXALIplatin injection) 5 mg/mL Injection, 50 mg, Rx only, Mfd. for: sanofi aventis US LLC Bridgewater, NJ 08807, NDC 0024-0590-10

D-1407-2012
Recall number
D-1407-2012
Initiated
February 06, 2012
Classification
Class II
Status
Terminated
Recalling firm
sanofi-aventis US, Inc.
Quantity
196,355 vials

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: Eloxatin was manufactured by Ben Venue Laboratories, a contract manufacturer, which was recently inspected by the agency and revealed significant issues in Good Manufacturing Practices.

Code information

Lot number and expiration dates Eloxatin¿ (OXALIplatin injection) 50mg vial AE41 02/ 2012 Eloxatin¿ (OXALIplatin injection) 50mg vial CA02B 02/ 2012 Eloxatin¿ (OXALIplatin injection) 50mg vial AE27 02/ 2012 Eloxatin¿ (OXALIplatin injection) 50mg vial BL18B 06/ 2012 Eloxatin¿ (OXALIplatin injection) 50mg vial CB13B 06/ 2012 Eloxatin¿ (OXALIplatin injection) 50mg vial CD65B 01/ 2014 Eloxatin¿ (OXALIplatin injection) 50mg vial CE39B 01/ 2014

Distribution pattern

Nationwide.

drug · product 2 of 2

Eloxatin (OXALIplatin injection) 5 mg/mL injection, 100 mg, Rx only, Mfd. for: sanofi aventis US LLC Bridgewater, NJ 08807, NDC 0024-0591-20

D-1408-2012
Recall number
D-1408-2012
Initiated
February 06, 2012
Classification
Class II
Status
Terminated
Recalling firm
sanofi-aventis US, Inc.
Quantity
387,738 vials

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
CGMP Deviations

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

CGMP Deviations: Eloxatin was manufactured by Ben Venue Laboratories, a contract manufacturer, which was recently inspected by the agency and revealed significant issues in Good Manufacturing Practices.

Code information

Lot number and expiration dates Eloxatin¿ (OXALIplatin injection) 100mg vial AD21 02/ 2012 Eloxatin¿ (OXALIplatin injection) 100mg vial AD22 02/ 2012 Eloxatin¿ (OXALIplatin injection) 100mg vial AE24 02/ 2012 Eloxatin¿ (OXALIplatin injection) 100mg vial AE25 02/ 2012 Eloxatin¿ (OXALIplatin injection) 100mg vial AF55 02/ 2012 Eloxatin¿ (OXALIplatin injection) 100mg vial AE26 03/ 2012 Eloxatin¿ (OXALIplatin injection) 100mg vial AF03 03/ 2012 Eloxatin¿ (OXALIplatin injection) 100mg vial AF04 03/ 2012 Eloxatin¿ (OXALIplatin injection) 100mg vial AF21 03/ 2012 Eloxatin¿ (OXALIplatin injection) 100mg vial BL19B 03/ 2012 Eloxatin¿ (OXALIplatin injection) 100mg vial CB11B 04/ 2012 Eloxatin¿ (OXALIplatin injection) 100mg vial CB102B 04/ 2012 Eloxatin¿ (OXALIplatin injection) 100mg vial CB12B 04/ 2012 Eloxatin¿ (OXALIplatin injection) 100mg vial CA01B 04/ 2012 Eloxatin¿ (OXALIplatin injection) 100mg vial BH07 06/ 2012 Eloxatin¿ (OXALIplatin injection) 100mg vial BH08 06/ 2012 Eloxatin¿ (OXALIplatin injection) 100mg vial BH09 06/ 2012 Eloxatin¿ (OXALIplatin injection) 100mg vial CC109B 01/ 2014

Distribution pattern

Nationwide.

Field note

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