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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 63691

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
October 08, 2012
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
GlaxoSmithKline, LLC.

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

1 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 1

Arranon (nelarabine) Injection 5mg/mL, 50mL Vials, Rx only, For I.V. Infusion only, GlaxoSmith Kline, Research Triangle Park, NC 27709. Made in England, NDC 0007-4401-06

D-068-2013
Recall number
D-068-2013
Initiated
October 08, 2012
Classification
Class II
Status
Terminated
Recalling firm
GlaxoSmithKline, LLC.
Quantity
1,319 vials

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Impurities/Degradation Products: Potential for drug related impurities to exceed the specification limits.

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Impurities/Degradation Products: Potential for drug related impurities to exceed the specification limits.

Code information

Lot # C536707 Exp 02/14, C538830 Exp.02/14, C533169 Exp. 02/14

Distribution pattern

Nationwide