Dextrose Injection, Solution
FDA Recall NDC 0409-7100

FDA Enforcement Report: View Recall Date, Reasons, and Safety Status

Active & Historical Enforcement Reports

The FDA has identified 2 recorded enforcement report(s) associated with Dextrose (NDC 0409-7100). A significant event, classified as Class II, was initiated on Nov 30, 2021 by Hospira, Inc.. The reported reason for this action was: "Lack of sterility assurance: bag has the potential to leak."

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-0265-2022TERMINATEDD-0417-2015TERMINATED

November 2021 Class II Recall: Lack of sterility assurance

Recall Number
D-0265-2022
Class II Terminated
Reason for Recall
Lack of sterility assurance: bag has the potential to leak.
Initiated
Nov 30, 2021
Reported
Dec 08, 2021
Quantity
765 bags

Recall Profile & Regulatory Data

Event ID
89100
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Pfizer Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA Nationwide
Termination Date
Jul 12, 2023
Product Description
5% Dextrose Injection, USP, 50 mL ADD-Vantage Unit, Rx only, Distributed by Hospira, INC., Lake Forest, IL 60045 USA, NDC 0409-7100-68/0409-7100-66
Batch or Lot Expiration Information
Lot# Lot: 4923608 Exp. 1MAY2022
Affected Packages Involved in this Recall
0409-7100-68Product
0409-7100-66Product
0409-7100-69Product
0409-7100-67Product
0409-7100-04Product
0409-7100-02Product

March 2015 Class II Recall: Lack of Assurance of Sterility

Recall Number
D-0417-2015
Class II Terminated
Reason for Recall
Lack of Assurance of Sterility: there is a potential for solution to leak at the administrative port of the primary container.
Initiated
Mar 05, 2015
Reported
Mar 25, 2015
Quantity
94,440 bags

Recall Profile & Regulatory Data

Event ID
70642
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Hospira Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Dec 09, 2016
Product Description
5% DEXTROSE Injection, USP, 250 mL ADD-Vantage Unit bag (NDC 0409-7100-02), UPC (01)0030404097100026; packaged in 24 bags per case pack (NDC 0409-7100-02), UPC (01)30304097100027(30)01, Rx ONLY, Hospira, Inc., Lake Forest, IL 60045.
Batch or Lot Expiration Information
Lot# Lot: 37-042-JT, Exp 1JAN2016
Affected Packages Involved in this Recall
0409-7100-68Product
0409-7100-66Product
0409-7100-69Product
0409-7100-67Product
0409-7100-04Product
0409-7100-02Product
0030404097Product
3030409710Product

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.