Recall Enforment Report D-0153-2018

Drug Recall Enforcement Report Class III voluntary initiated by Sanofi-Aventis U.S. LLC, originally initiated on 12-05-2017 for the product 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 The product was recalled due to 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. The product was distributed nationwide and the recall is currently terminated.

Field Name Field Value
Event ID 78637 What is the Event ID?
A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number D-0153-2018 What is the Recall Number?
An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences. What is the Recall Classification?
Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern Distributed nationwide. What is the Distribution Pattern?
General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
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 What is the Reason for Recall?
Information describing how the product is defective.
Product Quantity 11,474 cartons of 10 syringes per carton Product Quantity
The amount of product subject to recall.
Voluntary Mandated Voluntary: Firm initiated Voluntary / Mandated
Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date 01-17-2018
Recall Initiation Date 12-05-2017 What is the Recall Initiation Date?
The date that the firm first began notifying the public or their consignees of the recall.
Termination Date 10-11-2019 What is the Date Terminated?
The date that FDA terminated the recall.
Initial Firm Notification Letter Initial Firm Notification of Consignee or Public
The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type Drugs
Recalling Firm Sanofi-Aventis U.S. LLC
Code Info Lot #: 7S572, Exp. 04/2019 Code Information
A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages 0955-1003-01; 0955-1003-10; 0955-1004-01; 0955-1004-10; 0955-1006-01; 0955-1006-10; 0955-1008-01; 0955-1008-10; 0955-1010-01; 0955-1010-10; 0955-1016-01; 0955-1012-01; 0955-1012-10; 0955-1015-01; 0955-1015-10
Status Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
0955-1003Enoxaparin Sodium Enoxaparin SodiumInjectionSubcutaneousWinthrop U.s, A Business Of Sanofi-aventis U.s. LlcHuman Prescription Drug
0955-1004Enoxaparin Sodium Enoxaparin SodiumInjectionSubcutaneousWinthrop U.s, A Business Of Sanofi-aventis U.s. LlcHuman Prescription Drug
0955-1006Enoxaparin Sodium Enoxaparin SodiumInjectionSubcutaneousWinthrop U.s, A Business Of Sanofi-aventis U.s. LlcHuman Prescription Drug
0955-1008Enoxaparin Sodium Enoxaparin SodiumInjectionSubcutaneousWinthrop U.s, A Business Of Sanofi-aventis U.s. LlcHuman Prescription Drug
0955-1010Enoxaparin Sodium Enoxaparin SodiumInjectionSubcutaneousWinthrop U.s, A Business Of Sanofi-aventis U.s. LlcHuman Prescription Drug
0955-1012Enoxaparin Sodium Enoxaparin SodiumInjectionSubcutaneousWinthrop U.s, A Business Of Sanofi-aventis U.s. LlcHuman Prescription Drug
0955-1015Enoxaparin Sodium Enoxaparin SodiumInjectionSubcutaneousWinthrop U.s, A Business Of Sanofi-aventis U.s. LlcHuman Prescription Drug
0955-1016Enoxaparin Sodium Enoxaparin SodiumInjectionSubcutaneousWinthrop U.s, A Business Of Sanofi-aventis U.s. LlcHuman Prescription Drug