Exact FDA event identifier

Event 86219

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

Event summary

Timeline bucket: August 10, 2020
Product types: Drug
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: Sanofi-Aventis U.S. 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

Device root-cause evidence is not applicable to this event. No grouped product has the official product type device; this is not an unavailable-enrichment finding.

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

Elitek (rasburicase) for injection, 7.5 mg vial, Rx Only Mfd. by Sanofi - Aventis U. S. LLC Bridgewater, NJ, 08807, NDC 0024-5151-75

D-1507-2020

Recall number: D-1507-2020
Initiated: August 10, 2020
Classification: Class II
Status: Ongoing
Recalling firm: Sanofi-Aventis U.S. LLC
Quantity: 7451 vials

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

Out of Specification

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Failed Stability Specifications: Out of Specification result for enzyme activity levels noted during routine stability testing.

Code information

Lot #: A9306, Exp 2/28/2022

Distribution pattern

Nationwide in the US