Exact FDA event identifier

Event 78637

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

Event summary

Timeline bucket: December 05, 2017
Product types: Drug
Classifications: Class III
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

Enoxaparin Sodium, Injection 120 mg/0.8 mL, pre-filled, packaged in 10-count cartons, Rx Only, Winthrop US., a business of Sanofi-aventis, U.S. LLC Bridgewater, NJ 08807, NDC 0955-1012-10

D-0153-2018

Recall number: D-0153-2018
Initiated: December 05, 2017
Classification: Class III
Status: Terminated
Recalling firm: Sanofi-Aventis U.S. LLC
Quantity: 11,474 cartons of 10 syringes per carton

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

Labeling: Label Error

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Labeling: Label Error on Declared Strength. A single syringe labeled as 150 mg/1.0 mL was found packaged in a blister labeled as 120 mg/mL

Code information

Lot #: 7S572, Exp. 04/2019

Distribution pattern

Distributed nationwide.