Hextend Injection, Solution
FDA Recall NDC 0409-1555
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 Hextend (NDC 0409-1555). A significant event, classified as Class II, was initiated on Oct 22, 2012 by Hospira, Inc.. The reported reason for this action was: "Lack of Assurance of Sterility: There is the potential for the solution to leak from the seal of the fill tube to the 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: There is the potential for the solution to leak from the seal of the fill tube to the bag.
Oct 22, 2012
Mar 13, 2013
11,412 bags
Recall Profile & Regulatory Data
Event ID
63522
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Hospira Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Mar 31, 2015
Product Description
HEXTEND 6% Hetastarch in Lactated Electrolyte Injection, 500 mL, Rx only , MANUFACTURED AND DISTRIBUTED BY HOSPIRA, INC., LAKE FOREST, IL 60045, NDC 0409-1555-54
Batch or Lot Expiration Information
Lot# 10-199-JT Exp. 10/13
Affected Packages Involved in this Recall
0409-1555-64Product
0409-1555-54Product
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.
