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Enoxaparin Sodium, Injection 120 mg/0.8 mL, pre-filled, packaged in 10-count cartons, Rx Only, Wi...

FDA Recall #D-0153-2018 — Class III — December 5, 2017

Recall #D-0153-2018 Date: December 5, 2017 Classification: Class III Status: Terminated

Product Description

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

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

Recalling Firm

Sanofi-Aventis U.S. LLC — Bridgewater, NJ

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product Quantity

11,474 cartons of 10 syringes per carton

Distribution

Distributed nationwide.

Code Information

Lot #: 7S572, Exp. 04/2019

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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