Exact FDA event identifier

Event 79964

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

Event summary

Timeline bucket: April 27, 2018
Product types: Drug
Classifications: Class II
Statuses: Terminated
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

Docetaxel injection concentrate, 20 mg/mL, 1 mL vial, Rx only, Winthrop U.S. a business of Sanofi-Aventis U.S. LLC., NDC 0955-1020-01

D-0804-2018

Recall number: D-0804-2018
Initiated: April 27, 2018
Classification: Class II
Status: Terminated
Recalling firm: Sanofi-Aventis U.S. LLC
Quantity: 19580 vials

App-derived interpretation

Potency or specification failure reason.potency_specification_failure · v1.0.0

Superpotent

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Superpotent drug: over-concentrated vials of Docetaxel injection concentrate 20 mg/mL may have been distributed.

Code information

Lot #: 7F307A, 7F307C, Exp 01/2019

Distribution pattern

US nationwide