Heparin Sodium Injection, Solution
FDA Recall NDC 0409-2222
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 3 recorded enforcement report(s) associated with Heparin Sodium (NDC 0409-2222). A significant event, classified as Class II, was initiated on Dec 29, 2022 by Hospira, Inc.. The reported reason for this action was: "Lack of assurance of sterility: Bags have the potential to leak."
This specific recall has a current status of COMPLETED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of COMPLETED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Completed
Lack of assurance of sterility: Bags have the potential to leak.
Dec 29, 2022
Jan 11, 2023
62,088 bags
Recall Profile & Regulatory Data
Event ID
91379
Classification
Class II
Enforcement Status
Completed
Recalling Firm
Pfizer Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA.
Product Description
Heparin Sodium 2,000, USP Units, per 1,000 mL (2 USP Units/mL) in 0.9% Sodium Chloride Injection, 1,000 mL bags, a) Case (NDC 0409-7620-59), b) Single Unit (NDC 0409-7620-49), Rx only, Distributed By Hospira, Inc., Lake Forest, IL 60045 USA,
Batch or Lot Expiration Information
Lot# Lot: 5935283, Exp. 12/01/2023
Affected Packages Involved in this Recall
0409-7620-13Product
0409-7620-03Product
0409-7620-49Product
0409-7620-59Product
0409-1005-01Product
0409-1005-20Product
0409-2222-01Product
0409-2222-12Product
Class I Terminated
Presence of Particulate Matter: A particulate, confirmed as human hair, was found sealed between the tube and film at the round seal of the unused administrative port of the container.
Sep 11, 2014
Dec 31, 2014
63,378 flexible container units
Recall Profile & Regulatory Data
Event ID
69214
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Hospira Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Jan 04, 2016
Product Description
HEPARIN SODIUM, 1000 USP Heparin Units/500 mL (2 USP Heparin Units/mL), in 0.9% Sodium Chloride Injection, 500 mL flexible container unit, Rx only, Hospira Inc., Lake Forest, IL 60045, NDC 0409-7620-03
Batch or Lot Expiration Information
Lot# : 41-046-JT, Exp 11/01/2015
Affected Packages Involved in this Recall
0409-7620-13Product
0409-7620-03Product
0409-7620-49Product
0409-7620-59Product
0409-1005-01Product
0409-1005-20Product
0409-2222-01Product
0409-2222-12Product
January 2014 Class II Recall: Lack of Assurance of Sterility; potential leakage from administrative port.
Recall Number
Class II Terminated
Lack of Assurance of Sterility; potential leakage from administrative port.
Jan 09, 2014
Feb 05, 2014
27780 bags
Recall Profile & Regulatory Data
Event ID
67317
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Hospira Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide including Puerto Rico
Termination Date
May 19, 2015
Product Description
Heparin Sodium 2000 USP Heparin Units per 1000 mL (2 USP Heparin Units/mL) in 0.9% Sodium Chloride Injection, Rx only. Hospira, Lake Forest, IL 60045. NDC 0409-7620-59.
Batch or Lot Expiration Information
Lot# : 26-125-JT, Exp: 8/14
Affected Packages Involved in this Recall
0409-7620-13Product
0409-7620-03Product
0409-7620-49Product
0409-7620-59Product
0409-1005-01Product
0409-1005-20Product
0409-2222-01Product
0409-2222-12Product
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.
