Sanofi-Aventis U.S. LLC recalls Enoxaparin Sodium, Injection 120 mg/0.8 mL, pre-filled, packaged in 10-count cartons, Rx Only, Winthrop US., a business…

Recall date

December 5, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0153-2018

FDA classification

Class III

Brand / firm

Sanofi-Aventis U.S. LLC

Sold / distributed

Distributed nationwide.

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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