Heparin Sodium And Dextrose
FDA Recall NDC 0409-7793
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.
The FDA has identified 1 recorded enforcement report(s) associated with Heparin Sodium And Dextrose (NDC 0409-7793). A significant event, classified as Class II, was initiated on Jun 06, 2014 by Hospira, Inc.. The reported reason for this action was: "Lack of Assurance of Sterility: Confirmed consumer report of fluid leaking from primary container of bag."
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 II Terminated
Lack of Assurance of Sterility: Confirmed consumer report of fluid leaking from primary container of bag.
Jun 06, 2014
Jul 16, 2014
142,152 bags
Recall Profile & Regulatory Data
Event ID
68631
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Hospira Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Apr 03, 2015
Product Description
Heparin Sodium in 5% Dextrose Injection, Heparin, 25,000 USP Heparin Units/250 mL (100 USP Heparin Units/mL), 250 mL, Single-Dose Container, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-7793-62
Batch or Lot Expiration Information
Lot# 34-811-KL, 36-106-KL, 36-114-KL; Exp. 12/15; 36-101-KL, Exp. 12/15; 37-202-KL, Exp. 1/16; 38-302-KL, Exp. 2/16; 38-305-KL, Exp. 2/16
Affected Packages Involved in this Recall
0409-7793-52Product
0409-7793-62Product
0409-7793-13Product
0409-7793-23Product
0409-7794-52Product
0409-7794-62Product
0409-4520-02Product
0409-4520-30Product
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.
