Heparin Sodium In Sodium Chloride Injection, Solution
FDA Recall NDC 0338-0433
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 4 recorded enforcement report(s) associated with Heparin Sodium In Sodium Chloride (NDC 0338-0433). A significant event, classified as Class I, was initiated on Aug 01, 2024 by Baxter Healthcare Corporation. The reported reason for this action was: "Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
August 2024 Class I Recall: Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
Recall Number
Class I Ongoing
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
Aug 01, 2024
Sep 11, 2024
44,208 containers
Recall Profile & Regulatory Data
Event ID
95102
Classification
Class I
Enforcement Status
Ongoing
Recalling Firm
Baxter Healthcare Corporation
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
Heparin (Heparin Sodium in 0.9% Sodium Chloride Injection), 2,000 units per 1,000 mL (2 units/mL), 1000 mL Sterile Single Dose Container, Rx Only, Baxter USA, NDC 0338-0433-04
Batch or Lot Expiration Information
Lot# N008235, Exp 8/31/2024
Affected Packages Involved in this Recall
0338-0431-03Product
0338-0433-04Product
0338-0424-18Product
0338-0428-12Product
June 2015 Class II Recall: Subpotent Drug; out of specification results for heparin raw material
Recall Number
Class II Terminated
Subpotent Drug; out of specification results for heparin raw material
Jun 03, 2015
Jun 17, 2015
145,350 containers
Recall Profile & Regulatory Data
Event ID
71356
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Baxter Healthcare Corp
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Mar 14, 2017
Product Description
Heparin Sodium and 0.9% Sodium Chloride Injection, 1000 USP Heparin Units, 500 mL in a VIAFLEX Plus Container, Rx Only, Baxter Healthcare Corporation, Deerfield, IL --- NDC 0338-0431-03
Batch or Lot Expiration Information
Lot# Product Code: 280953 Lots: N002998 and N003004 exp 12/31/15; and lot N003038 exp. 01/31/2016
Affected Packages Involved in this Recall
0338-0431-03Product
0338-0433-04Product
0338-0424-18Product
0338-0428-12Product
Class II Terminated
Subpotent Drug: Heparin raw material was found to have low potency
Oct 30, 2014
Dec 03, 2014
127,746 Viaflex Plus Container
Recall Profile & Regulatory Data
Event ID
69634
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Baxter Healthcare Corp.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Sep 22, 2016
Product Description
Heparin Sodium in 0.9% Sodium Chloride Injection, 1000 USP Heparin Units, 500 mL in a VIAFLEX Plus Container, Rx only, Manufactured for Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015 by Baxter Healthcare Corporation 250 Road 144 Jayuya, Puerto Rico, 00664, NDC 0338-0431-03
Batch or Lot Expiration Information
Lot# : N003061; N003079; and N003087, Exp 2/29/2016
Affected Packages Involved in this Recall
0338-0431-03Product
0338-0433-04Product
0338-0424-18Product
0338-0428-12Product
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
N/A
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
Heparin Sodium and 0.9% Sodium Chloride Injection, a) Product code 2B0944, 2000 USP Units, Viaflex Plus Container, 1000mL, (NDC 0338-0433-04), b) Product code 2B0953: 1000 USP Units, Viaflex Plus Container, 500 mL (NDC 0338-0431-03), Baxter, Deerfield, IL 60015
Batch or Lot Expiration Information
Lot# : a) Product code 2B0944: N001164, Exp 7/13; b) Product code 2B0953: N001396, Exp 11/13
Affected Packages Involved in this Recall
0338-0431-03Product
0338-0433-04Product
0338-0424-18Product
0338-0428-12Product
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.
