Dextrose Injection, Solution
FDA Recall NDC 0338-0023
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 6 recorded enforcement report(s) associated with Dextrose (NDC 0338-0023). A significant event, classified as Class II, was initiated on Jul 06, 2017 by Baxter Healthcare Corporation. 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 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: Bags have the potential to leak.
Jul 06, 2017
Jul 19, 2017
54,528 bags
Recall Profile & Regulatory Data
Event ID
77676
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Baxter Healthcare Corporation
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide, Puerto Rico and Saudi Arabia
Termination Date
Apr 29, 2020
Product Description
5% Dextrose Injection, USP, 100 mL VIAFLEX Plastic Container, Rx only, Baxter Healthcare Corporation, Deerfield IL 60015 USA, Product Code: 2B0089, NDC: 0338-0017-38
Batch or Lot Expiration Information
Lot# Lot: P361618, Exp 09/30/18
Affected Packages Involved in this Recall
0338-0017-10Product
0338-0017-41Product
0338-0017-11Product
0338-0017-31Product
0338-0017-48Product
0338-0017-18Product
0338-0017-38Product
0338-0017-02Product
0338-0017-03Product
0338-0017-04Product
0338-0023-02Product
0338-0023-03Product
0338-0023-04Product
Class I Terminated
Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)
Mar 24, 2015
Jul 15, 2015
18,324 bags
Recall Profile & Regulatory Data
Event ID
70926
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Baxter Healthcare Corp.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
US, Puerto Rico, and Bermuda
Termination Date
Feb 07, 2017
Product Description
10% Dextrose Injection, USP, 250mL VIAFLEX Plastic bags, Manufactured by Baxter Healthcare Corporation 65 Pitts Station Road Marion, North Carolina 28752-7925 for Baxter Healthcare Corporation 1 Baxter Pkwy Deerfield, IL 60015-4625. NDC 0338-0023-02
Batch or Lot Expiration Information
Lot# : C965558 and C963520, Exp 7/31/2016
Affected Packages Involved in this Recall
0338-0017-10Product
0338-0017-41Product
0338-0017-11Product
0338-0017-31Product
0338-0017-48Product
0338-0017-18Product
0338-0017-38Product
0338-0017-02Product
0338-0017-03Product
0338-0017-04Product
0338-0023-02Product
0338-0023-03Product
0338-0023-04Product
Class I Terminated
Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)
Mar 24, 2015
Jul 15, 2015
402,284 bags
Recall Profile & Regulatory Data
Event ID
70926
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Baxter Healthcare Corp.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
US, Puerto Rico, and Bermuda
Termination Date
Feb 07, 2017
Product Description
5% Dextrose Injection, USP, 250mL VIAFLEX Plastic bags, Manufactured by Baxter Healthcare Corporation 65 Pitts Station Road Marion, North Carolina 28752-7925 for Baxter Healthcare Corporation 1 Baxter Pkwy Deerfield, IL 60015-4625. NDC 0338-0017-02
Batch or Lot Expiration Information
Lot# : C963413 and C963413A, Exp 7/31/2016
Affected Packages Involved in this Recall
0338-0017-10Product
0338-0017-41Product
0338-0017-11Product
0338-0017-31Product
0338-0017-48Product
0338-0017-18Product
0338-0017-38Product
0338-0017-02Product
0338-0017-03Product
0338-0017-04Product
0338-0023-02Product
0338-0023-03Product
0338-0023-04Product
March 2015 Class II Recall: Lack of Assurance of Sterility. Complaints were receive of missing closures and/or leaks which may compromise product sterility.
Recall Number
Class II Terminated
Lack of Assurance of Sterility. Complaints were receive of missing closures and/or leaks which may compromise product sterility.
Mar 18, 2015
Apr 01, 2015
48,874
Recall Profile & Regulatory Data
Event ID
70770
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Baxter Healthcare Corp.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Feb 24, 2016
Product Description
5% Dextrose Injection, USP, 1000mL in VIAFLEX Plastic Container, Rx only, Manufactured by Baxter Healthcare Corp., North Cove, North Carolina Facility Highway 221 North, Marion, NC 28752 for Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015. NDC 0338-0017-04
Batch or Lot Expiration Information
Lot# : C926899, Exp 7/31/2015
Affected Packages Involved in this Recall
0338-0017-10Product
0338-0017-41Product
0338-0017-11Product
0338-0017-31Product
0338-0017-48Product
0338-0017-18Product
0338-0017-38Product
0338-0017-02Product
0338-0017-03Product
0338-0017-04Product
0338-0023-02Product
0338-0023-03Product
0338-0023-04Product
November 2013 Class I Recall: Presence of Paticulate Matter; Baxter is issuing a voluntary recall for these IV solutions due to particulate matter found in the solution identified as polyester and cotton fibers, adhesive-like mixture, polyacetal particles, thermally degraded PVC, black polypropylene and human hair embedded in the plastic bag
Recall Number
Class I Terminated
Presence of Paticulate Matter; Baxter is issuing a voluntary recall for these IV solutions due to particulate matter found in the solution identified as polyester and cotton fibers, adhesive-like mixture, polyacetal particles, thermally degraded PVC, black polypropylene and human hair embedded in the plastic bag
Nov 21, 2013
Mar 26, 2014
105,216 containers
Recall Profile & Regulatory Data
Event ID
67092
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Baxter Healthcare Corp.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide, Puerto Rico, Singapore, Saudi Arabia and United Arab Emirates.
Termination Date
Sep 21, 2016
Product Description
5% Dextrose Injection, USP, 100 mL Single dose VIAFLEX plastic containers, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Product code 2B0089, NDC 0338-0017-38.
Batch or Lot Expiration Information
Lot# : P285288, Exp 11/13
Affected Packages Involved in this Recall
0338-0017-10Product
0338-0017-41Product
0338-0017-11Product
0338-0017-31Product
0338-0017-48Product
0338-0017-18Product
0338-0017-38Product
0338-0017-02Product
0338-0017-03Product
0338-0017-04Product
0338-0023-02Product
0338-0023-03Product
0338-0023-04Product
Class II Terminated
Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for potential administration port leakage. The potential for leakage is the result of a manufacturing issue which occurred during the sealing of the closure assembly at the administration port.
May 21, 2013
Jul 10, 2013
730,848 units
Recall Profile & Regulatory Data
Event ID
65288
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Baxter Healthcare Corp.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide & Puerto Rico
Termination Date
Jun 18, 2015
Product Description
5% Dextrose Injection, USP, in VIAFLEX Plastic Container Multi Pack, Rx Only, a) 50 mL (NDC 0338-0017-31), b) 100 mL (NDC 0338-0017-38), Baxter, Deerfield, IL 60015
Batch or Lot Expiration Information
Lot# : a) Product code 2B0088: P280115, P285239, Exp 7/13; b) Product code 2B0089: P280230, P280461, P285288, P285288A, P285783, Exp 8/13
Affected Packages Involved in this Recall
0338-0017-10Product
0338-0017-41Product
0338-0017-11Product
0338-0017-31Product
0338-0017-48Product
0338-0017-18Product
0338-0017-38Product
0338-0017-02Product
0338-0017-03Product
0338-0017-04Product
0338-0023-02Product
0338-0023-03Product
0338-0023-04Product
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.
