Enoxaparin Sodium Injection
FDA Recall NDC 0955-1012
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Enoxaparin Sodium (NDC 0955-1012). A significant event, classified as Class III, was initiated on Dec 05, 2017 by Sanofi-aventis U.s. Llc. The reported reason for this action was: "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"
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class III Terminated
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
Dec 05, 2017
Jan 17, 2018
11,474 cartons of 10 syringes per carton
Recall Profile & Regulatory Data
Event ID
78637
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Sanofi-Aventis U.S. LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed nationwide.
Termination Date
Oct 11, 2019
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
Batch or Lot Expiration Information
Lot# : 7S572, Exp. 04/2019
Affected Packages Involved in this Recall
0955-1003-01Product
0955-1003-10Product
0955-1004-01Product
0955-1004-10Product
0955-1006-01Product
0955-1006-10Product
0955-1008-01Product
0955-1008-10Product
0955-1010-01Product
0955-1010-10Product
0955-1016-01Product
0955-1012-01Product
0955-1012-10Product
0955-1015-01Product
0955-1015-10Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
