Heparin Sodium Injection, Solution
FDA Recall NDC 63323-047

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 Heparin Sodium (NDC 63323-047). A significant event, classified as Class II, was initiated on Jan 22, 2014 by Fresenius Kabi Usa, Llc. The reported reason for this action was: "Subpotent; 18 month time point"

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

D-1148-2014TERMINATED

January 2014 Class II Recall: Subpotent; 18 month time point

Recall Number
D-1148-2014
Class II Terminated
Reason for Recall
Subpotent; 18 month time point
Initiated
Jan 22, 2014
Reported
Mar 12, 2014
Quantity
161,650 vials

Recall Profile & Regulatory Data

Event ID
67330
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Fresenius Kabi USA, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
May 24, 2016
Product Description
Heparin Sodium Injection, USP 10,000 USP units per 10 mL (1,000 USP units per mL) For IV or SC use, Multi-Dose Vial, Rx only, NDC 63323-540-11, 25 vials in tray, each boxed vial individually labeled as: Heparin Sodium Injection, USP 10,000 USP units per 10 mL (1,000 USP units per mL) For IV or SC use, Multi-Dose Vial, Rx only, NDC 63323-540-11.
Batch or Lot Expiration Information
Lot# Lot Number: 6004137, Expiration date: 06/2014
Affected Packages Involved in this Recall
63323-542-01Product
63323-542-07Product
63323-276-01Product
63323-276-02Product
63323-915-01Product
63323-047-01Product
63323-047-10Product
63323-543-02Product
63323-459-09Product
63323-540-01Product
63323-540-11Product
63323-540-31Product
63323-262-01Product

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.